UK

United Kingdom · Compliance, quality and safety · 16-20 years

Chief Quality & Regulatory Officer

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  • Experience band16-20 years
  • Reports toChief Executive Officer (CEO) and Board of Directors
  • UK framework levelUsually an executive or board-level role

Also advertised as VP, Global Quality & Regulatory Affairs · Chief Compliance Officer · Executive Director of Enterprise Quality · Head of Global Quality & Assurance

Built on 43,079 real UK job descriptions we analysed · grounded in what real qualifications cover

Two short quizzes about you

1From this job to a course

The qualifications matched to this job

GQA Level 5 Diploma in the Practice of Process Safety Management GQA Qualifications Limited · Level 5 · covers 3 of 10 standards
GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician) GQA Qualifications Limited · Level 3 · covers 1 of 10 standards
GQA PAA\VQ-SET Level 3 Certificate in Laboratory Technical Skills GQA Qualifications Limited · Level 3 · covers 1 of 10 standards
CICM Level 5 Diploma in Credit and Collections Management Chartered Institute of Credit Management · Level 5 · covers 1 of 10 standards
ProQual Level 6 NVQ Diploma in Quality Management ProQual Awarding Body · Level 6 · covers 1 of 10 standards

Matched from the standards this job is measured against: a suggestion, not an official ruling.

The units you would start with

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Level 5 Diploma in the Practice of Process Safety Management
Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards Level 3 Technical Occupational Entry in the Principles and Practice for Pharmacy Technicians (Diploma)
Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician)
Good Manufacturing Practice GQA PAA\VQ-SET Level 3 Certificate in Laboratory Technical Skills
Compliance with legal, regulatory, ethical and social requirements CICM Level 5 Diploma in Credit and Collections Management
Quality Management Systems and Standards ProQual Level 6 NVQ Diploma in Quality Management

The future skills this job leans on

AI Fluency working with AI as a thinking partner
AI Governance Fluency using AI responsibly
Sustainability Fluency building care for people and planet into the work
Foresight Fluency seeing round the corner
Systems Fluency seeing the whole picture
Your Plan Illustration

Built for Chief Quality & Regulatory Officer

6 units that map to this job, from the qualifications that cover it.

  1. Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Qualifications Limited · covers 3 of 10 standards Level 5
  2. Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards · covers 2 of 10 standards Level 3
  3. Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA Qualifications Limited · covers 1 of 10 standards Level 3
  4. Good Manufacturing Practice GQA Qualifications Limited · covers 1 of 10 standards Level 3
  5. Compliance with legal, regulatory, ethical and social requirements Chartered Institute of Credit Management · covers 1 of 10 standards Level 5
  6. Quality Management Systems and Standards ProQual Awarding Body · covers 1 of 10 standards Level 6
These are the real units behind this job, in the order they rank for it. Nothing here is marked done, because this plan has not been started by anyone yet. Yours would fill in as you go.

2AI and this work

Will AI change your work as a Chief Quality & Regulatory Officer?

Nobody can say exactly how. Here is what this job is being asked for next, and where to start.

The new skills this role is being asked for

  • AI Governance & Ethical AI in Quality
  • Global Supply Chain Resilience & Geopolitical Risk
Why each one is rising

The future skills this job leans on

We'll only ever tell you what we can actually back up. No hype, no scare tactics.

What happens when you start

Next, a free account. We build your Chief Quality & Regulatory Officer plan as you set up, starting with the free Automation Fluency module. No card.

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3What this role really is

This role carries final accountability for quality and regulatory standing across an organisation. You are the person a CEO and Board turn to when there is a major recall, a critical audit finding, or new legislation that could threaten the business. You act as strategic lead, public face, and guardian of reputation and market access across every product and market.

4What you'd actually use

The tools this job runs on, and how well you'd need to know each one.

eQMS Platform (e.g., MasterControl, Veeva QualityDocs, TrackWise Digital) Strategic

Leads the selection, strategic deployment, and integration of enterprise-grade eQMS platforms, ensuring they support global compliance, data integrity (CFR Part 11), and efficient quality processes across the entire organisation. Manages vendor relationships at an executive level.

ERP System (e.g., SAP S/4HANA QM, Oracle NetSuite) Architect

Designs the strategic integration points between the ERP and QMS. Defines master data governance for quality-relevant objects, ensuring seamless data flow and integrity across enterprise systems. Provides executive oversight for major system upgrades impacting quality.

GRC / Executive Reporting Platforms (e.g., ServiceNow GRC, Power BI, Tableau) Advanced

Designs and maintains executive-level Quality and Regulatory dashboards for the CEO and Board. Uses GRC platforms to link quality events to enterprise risk, providing a holistic view of the organisation's risk posture. Oversees the development of predictive analytics for quality trends.

Collaboration & Documentation Platforms (e.g., SharePoint, Confluence, MS Teams) Strategic

Establishes the enterprise-wide strategy for GxP-compliant collaboration and documentation platforms. Ensures secure, version-controlled environments for critical quality and regulatory documents, supporting global team collaboration and audit readiness.

AI/ML Platforms for Data Analysis & Prediction Strategic

Champions the adoption of AI/ML tools for predictive quality, global regulatory intelligence, and advanced trend analysis. Oversees the development of AI-driven insights for strategic decision-making in quality and regulatory affairs.

5What you get to decide, and how that grows

Power in a job isn't your title. It's what you're allowed to decide. Here's how it grows as you move up.

The choiceComing in Where you are nowThe step above
Enterprise Regulatory Strategy N/A N/A N/A
Major Product Recall / Market Withdrawal N/A N/A N/A
Global QMS Architecture & Investment N/A N/A N/A
M&A Quality & Regulatory Due Diligence N/A N/A N/A

6How you'll be judged

The scoreboard, and what is not on it. The hard targets, how often each is actually looked at, and the quiet signals that never reach a dashboard.

Cost of Poor Quality (CoPQ) Reduction
Overall reduction in costs associated with quality failures (e.g., scrap, rework, warranty claims, recalls, fines).
Target · >15% Year-over-Year Reduction in CoPQ as a % of Revenue

Reduced CoPQ from 4.5% of revenue to 3.8% in FY2024, saving £7M in direct costs and avoiding potential regulatory penalties.

Global Regulatory Compliance Status
Number and severity of regulatory observations, warning letters, or market withdrawals across all operating regions.
Target · Zero Major Regulatory Findings (e.g., FDA 483s, MHRA Critical Observations) and Zero Product Recalls Annually

Maintained a clean record with zero critical findings from any major regulatory body globally for three consecutive years, ensuring uninterrupted market access.

Customer Complaint Rate & Resolution
Reduction in the rate of customer complaints per unit sold and the average time to resolve critical complaints.
Target · >20% Year-over-Year Reduction in Complaint Rate; <5 days for Critical Complaint Closure

Decreased the global customer complaint rate by 25% last year, and consistently closed all critical complaints within 3 days, significantly boosting customer satisfaction scores.

QMS Maturity & Effectiveness Score
Internal or external assessment score reflecting the robustness, efficiency, and proactive nature of the enterprise QMS.
Target · Achieve 'Optimising' or 'Level 5' on QMS Maturity Model (e.g., CMMI for Quality)

Improved our QMS maturity score from 'Managed' to 'Optimising' in the last external assessment, demonstrating proactive risk management and continuous improvement.

Board & Executive Trust
The degree to which the Board and Executive Leadership Team rely on your strategic insights and guidance for critical business decisions involving quality and regulatory risk.
  • You're consistently invited to provide strategic input on M&A targets, new market entries, and major product development initiatives. Your recommendations are typically adopted without significant debate, demonstrating high confidence in your judgment. The CEO regularly references your insights in investor calls.
Proactive Regulatory Foresight
The ability to anticipate upcoming regulatory changes and position the organisation to adapt ahead of competitors, turning compliance into a strategic advantage.
  • You present regular updates to the Board on emerging global regulatory trends, with clear action plans. We're consistently among the first in our industry to comply with new standards, often influencing their development. Competitors are playing catch-up to our regulatory readiness.
Culture of Quality Leadership
Successfully embedding a 'quality-first' mindset across all functions, from R&D to Sales, where quality is seen as everyone's responsibility, not just the Quality department's.
  • Quality metrics are routinely discussed in all departmental leadership meetings, not just yours. Senior leaders from other functions actively champion quality initiatives. Employee surveys show high engagement with quality programmes and a clear understanding of their role in maintaining standards.

7Would you like it

Both sides. What people enjoy, and what grinds them down.

What people enjoy
Safeguarding Enterprise Value

You're driven by the profound responsibility of protecting the company's reputation, market access, and financial health. Every strategic decision, every regulatory interpretation, is viewed through the lens of long-term organisational resilience.

Leading the strategic response to a major new EU MDR update, ensuring our entire product portfolio remains compliant and avoiding market withdrawal, directly preserving hundreds of millions in revenue.

Shaping Industry Standards

You thrive on influencing the broader regulatory landscape, participating in industry bodies, and setting benchmarks for quality excellence that others aspire to. It's about moving the entire sector forward, not just our company.

Representing the company on a key industry association committee, successfully advocating for a pragmatic interpretation of a new global standard that benefits both our company and the wider industry.

Building a Legacy of Quality

Your ultimate goal is to embed a pervasive culture of quality that outlasts your tenure, making 'quality' synonymous with our brand. You're passionate about ensuring every product we ship is safe, effective, and reliable.

Overseeing a multi-year transformation of the global quality function, resulting in a measurable shift in employee mindset, a significant reduction in quality incidents, and external recognition for our quality leadership.

What frustrates people
  • Dealing with executive teams who prioritise short-term revenue over long-term regulatory integrity, forcing difficult conversations.
  • Navigating conflicting regulatory requirements across dozens of international markets, which can feel like an impossible puzzle.
  • The sheer volume of complex, high-stakes information that needs to be absorbed, analysed, and acted upon daily.
  • The political tightrope walk of reporting a major quality failure to the Board, knowing the financial and reputational implications.
  • Trying to integrate the QMS of a newly acquired company that has a completely different quality culture and inadequate systems.
  • The constant pressure of an impending regulatory audit, where the smallest oversight could lead to severe penalties.
What this role does not give you
  • A quiet, predictable work schedule; expect urgent requests and late nights when a crisis hits.
  • The luxury of delegating all difficult conversations; you'll be having the toughest ones.
  • A role where you can avoid public speaking or high-pressure presentations; it's a core part of the job.
  • A purely technical role; this is about enterprise strategy, leadership, and governance.

8Who you work with

This role is foundational to our enterprise's existence and growth. You'll directly influence market access, product launch timelines, brand reputation, and financial performance. Your decisions on regulatory strategy, risk tolerance, and quality investment will literally determine if we can sell our products and whether investors trust us. It's about protecting our licence to operate and ensuring long-term shareholder value through uncompromising quality and compliance.

Inside the business
  • CEO and Executive Leadership Team (ELT)
  • Board of Directors (Audit & Risk Committees)
  • General Counsel and Legal Department
  • Head of Product Development and R&D
  • Chief Operations Officer (COO) and Supply Chain Leadership
  • Chief Commercial Officer (CCO) and Sales Leadership
Outside the business
  • Global Regulatory Authorities (e.g., MHRA, FDA, EMA, TGA, Health Canada)
  • Notified Bodies and Registrars (e.g., BSI, TÜV)
  • Investors and Shareholders
  • Industry Associations and Standard Bodies
  • External Auditors and Legal Counsel
  • Key Strategic Partners and Major Customers

9What you need before you start

Not a wish list. The things you would be expected to already have.

  • A minimum of 20 years of progressive leadership experience in Quality and Regulatory Affairs, with at least 5-7 years at a Director or VP level, preferably within a global, highly regulated industry (e.g., Medical Devices, Pharma, Aerospace).
  • Demonstrated track record of successfully managing complex global regulatory inspections (e.g., FDA audits, Notified Body audits) with zero major findings.
  • Proven experience in developing and implementing enterprise-wide Quality Management Systems (QMS) and global regulatory strategies.
  • Significant experience leading and developing large, geographically dispersed teams of quality and regulatory professionals.
  • Demonstrated ability to influence and present to Board-level executives, investors, and external regulatory bodies.
  • A history of driving measurable reductions in Cost of Poor Quality (CoPQ) and improving overall product quality at an organisational level.

10What to practise next

Where the job is going, and what to do about it starting this week.

Advanced Predictive Analytics for Quality

Moving beyond reactive quality control, you'll need to champion the use of advanced predictive models to anticipate quality issues before they occur. This includes using machine learning to predict equipment failures, process deviations, or even potential customer complaints based on vast datasets.

IoT & Sensor Data Integration · Machine Learning for Anomaly Detection · Statistical Process Control (SPC) with AI Augmentation · Data Visualisation for Executive Insights

  • This quarter: Review the capabilities of our current data science team and identify a pilot project for predictive quality in one manufacturing line.
  • Next 6 months: Oversee the implementation of a predictive quality pilot, focusing on a critical process or product. Evaluate its effectiveness and ROI.
  • Next 12 months: Develop a roadmap for scaling predictive quality initiatives across the enterprise, including necessary technology investments and talent development.
  • Ongoing: Challenge your teams to move from reactive to proactive quality management through data-driven insights.

Quick win: Identify one critical manufacturing parameter that frequently goes out of specification. Work with your team to explore if existing data could be used to predict these excursions 24 hours in advance.

11Staying current once you are in

What people here do to keep up
  • Active participation in global industry associations (e.g., AdvaMed, PhRMA, RAPS) to influence regulatory policy and network with peers.
  • Regular attendance at executive-level conferences and forums on global quality, regulatory affairs, and enterprise risk management.
  • Engagement with academic institutions on emerging research in quality science, AI in regulation, or supply chain resilience.
  • Mentoring rising talent within the quality and regulatory function, both internally and externally.

12The rising capability

The rising capability

Zavmo analysis

What's rising in its place

This is where the work is heading, and the higher pay with it. Get fluent here and the shift stops being a threat and starts being your edge.

AI Governance & Ethical AI in Quality

AI is increasingly being used in product design, manufacturing, and quality control. As a C-suite leader, you'll need to establish the ethical frameworks, validation processes, and governance structures to ensure AI-driven systems are compliant, unbiased, and reliable, especially in regulated environments. The risks of 'algorithmic bias' or 'AI hallucinations' in quality decisions are immense.

  • AI Ethics & Bias Mitigation
  • AI Model Validation & Explainability (XAI)
  • Regulatory Compliance for AI/ML-driven Products
  • Data Governance for AI Training

Global Supply Chain Resilience & Geopolitical Risk

Recent global events (pandemics, geopolitical conflicts, trade wars) have highlighted the fragility of global supply chains. As CQRO, you'll need to architect quality systems that can withstand significant external shocks, ensuring continuity of supply and regulatory compliance even in highly volatile environments. This isn't just about supplier audits; it's about strategic geopolitical foresight.

  • Multi-Sourcing & Regionalisation Strategies
  • Real-time Supply Chain Monitoring
  • Geopolitical Risk Assessment & Mitigation
  • Digital Twin & Supply Chain Simulation

13What you’ll use

What you’ll use

Skills this role draws on

Technical

  • Global QMS Architecture & Governance
  • International Regulatory Strategy & Affairs
  • Advanced Root Cause Analysis & CAPA Governance
  • Supplier Quality & Supply Chain Resilience
  • M&A Quality & Regulatory Due Diligence & Integration

14The pathway

The pathway

How you actually get there, here

How you become one varies far more by country than what one does. This is the UK route. Most people take one of these ways in; the right one depends on where you're starting from.

  1. 1

    VP, Global Quality & Regulatory Affairs (from a large, complex organisation)

    3-5 years as a VP

    Skills to master

    • Enterprise-wide strategic planning, board-level reporting, M&A integration, and leading multi-functional executive teams. This is about expanding your scope from a large division to the entire enterprise.

    You're ready to move on when

    • Successfully led a major QMS transformation initiative across multiple international sites.
    • Consistently delivered zero major regulatory findings during your VP tenure.
    • Demonstrated ability to influence executive leadership and drive cross-functional quality initiatives.
    • Managed a significant P&L for a global quality and regulatory function.
  2. 2

    Chief Compliance Officer (from a heavily regulated industry)

    4-6 years as CCO

    Skills to master

    • Deep understanding of product-specific quality systems, manufacturing controls, and the interface between quality, regulatory, and legal compliance. This path requires broadening from pure compliance to also owning the quality system itself.

    You're ready to move on when

    • Successfully navigated complex regulatory enforcement actions and built robust compliance programmes.
    • Proven ability to manage relationships with multiple regulatory bodies and legal counsel.
    • Demonstrated leadership in ethical decision-making and fostering a culture of integrity.
    • Experience in risk assessment and mitigation across an entire enterprise.
  3. 3

    Senior Partner / Practice Lead (from a top-tier Quality/Regulatory Consulting Firm)

    5-7 years as Senior Partner

    Skills to master

    • Transitioning from advisory to direct operational accountability, building an internal team, and managing the political complexities of a corporate environment. This requires shifting from project-based work to long-term enterprise governance.

    You're ready to move on when

    • Led multiple large-scale QMS implementation or regulatory remediation projects for major clients.
    • Developed and managed a significant book of business and client relationships.
    • Demonstrated ability to influence C-suite clients and drive strategic change.
    • Experience in building and leading consulting teams.

15Where this role leads

The long view: This role sits at the top of a career in quality and regulatory affairs. It can lead to CEO or board level positions, or to shaping regulatory policy across an industry.

The ten Future Fluencies

Zavmo analysis

The credential is what you can do today. These are what keep you valuable.

A qualification proves you can do the job as it's defined today. These ten are what decide whether you're still the obvious person for it in five years. They're the capabilities employers are now writing into senior roles faster than people are learning them. Zavmo weaves them through whatever you study, so you come out with both: the credential and the fluency.

The highlighted ones are the Fluencies your role leans on hardest, from how Chief Quality & Regulatory Officer is actually changing.

Where it leads

Roles this leads to

The record names a next step, but the catalogue has no page for it yet:

  • Chief Executive Officer (CEO)
  • Board Member / Non-Executive Director (NED)

How you would learn this

One to one, on the work you already do

A tutor sets the task against your own job and marks the reasoning, at your pace. There is no cohort to fall behind.

A lesson from Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety, worked against Chief Quality & Regulatory Officer.

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety Level 5

Applied to your work in Chief Quality & Regulatory Officer

The objective of this unit is to provide learners with a comprehensive understanding of the regulations, industry standards, and management requirements for process safety. Learners will understand the role of the Process Safety Leadership Group, relevant frameworks, legal duties, and the role of the Competent Authority.

How the thinking builds
  1. 1 Remember
  2. 2 Understand
  3. 3 Apply
  4. 4 Analyse
  5. 5 Evaluate
  6. 6 Create
An illustration of a Zavmo lesson, built from this role’s own route. The unit, its objective and every criterion above are the awarding body’s own words, not an example.

It is £70 a month, billed monthly. Your free first module is Future Fluency, and you can cancel any time.

See Your Progress Grow Illustration
Chief Quality & Regulatory Officer
  • Global QMS Architecture & Governance
  • International Regulatory Strategy & Affairs
  • Advanced Root Cause Analysis & CAPA Governance
  • Supplier Quality & Supply Chain Resilience
  • M&A Quality & Regulatory Due Diligence & Integration
This is your Mind Palace on learn.zavmo.ai. Every skill above comes from this role's own record, not an example borrowed from another job. A node lights up when you evidence it, and what you build stays yours between jobs. That is the part a course cannot do.

16The detail, folded away

Everything else the record holds

The career branches in full, how AI is already showing up in the day-to-day, and the questions people ask about this job. Here when you want them, out of the way while you decide.

Where it leads next, rung by rung

Where it leads

The career path, and where it branches

Chief Quality & Regulatory Officer is a start, not a ceiling. Each step below asks for new skills and hands back more autonomy.

  1. Chief Executive Officer (CEO)

    5-10 years

    Enterprise Leadership

    • Deep understanding of commercial strategy, sales, and marketing.
    • Operational excellence across manufacturing and supply chain.
    • Financial modelling and strategic financial planning.
    • Talent management and executive succession planning.

  2. Board Member / Non-Executive Director (NED)

    3-7 years

    Governance & Oversight

    • Expertise in board dynamics and effective committee participation (e.g., Audit, Risk, Nomination).
    • Ability to provide independent, objective advice and guidance.
    • Strong network within the corporate governance community.
Working with AI on the job

Working with AI

Where AI is starting to help

At the C-suite level, AI isn't about automating mundane tasks; it's about augmenting your strategic capabilities, providing foresight, and enabling faster, more informed decisions that impact the entire enterprise. It's your secret weapon for navigating an increasingly complex global landscape.

Imagine having a co-pilot that sifts through millions of data points, anticipates regulatory shifts, and drafts board-level summaries in minutes. That's the power AI brings to the Chief Quality & Regulatory Officer. You'll use these tools to elevate your strategic impact, not just manage your inbox.

Global Regulatory Foresight Engine

Use AI to continuously scan, summarise, and predict the impact of emerging global regulatory changes (e.g., new FDA guidances, EU MDR updates, APAC requirements). Get concise, actionable intelligence on potential risks and opportunities before they hit, allowing proactive strategic adjustments. This isn't just monitoring; it's predicting.

Enterprise Risk & Quality Trend Analysis

Employ advanced AI/ML models to analyse vast, unstructured datasets from global customer complaints, audit findings, non-conformances, and supplier data across all business units. Identify systemic, cross-functional quality failure modes and emerging risk patterns that human analysis simply can't detect, informing your strategic investment decisions.

Board & Investor Relations Briefing Automation

Feed comprehensive quality performance reports, regulatory updates, and risk assessments into an AI to generate executive-level summaries, board presentations, and investor briefing documents. The AI can distil complex information into clear, concise narratives, saving you hours of drafting time and ensuring consistent messaging.

M&A Due Diligence & Integration AI

Use AI to rapidly assess the quality and regulatory risk profile of potential M&A targets by analysing their public filings, audit histories, and internal documentation (if accessible). Post-acquisition, AI can help map and harmonise disparate QMS processes, accelerating integration and reducing compliance gaps.

Common questions

Common questions

How do you become a Chief Quality & Regulatory Officer?

Common routes in include VP, Global Quality & Regulatory Affairs (from a large, complex organisation) (3-5 years as a VP), Chief Compliance Officer (from a heavily regulated industry) (4-6 years as CCO) and Senior Partner / Practice Lead (from a top-tier Quality/Regulatory Consulting Firm) (5-7 years as Senior Partner). Times vary with prior experience.

Where can a Chief Quality & Regulatory Officer progress to?

This role can lead on to Chief Executive Officer (CEO) (5-10 years) and Board Member / Non-Executive Director (NED) (3-7 years), depending on the skills you build.

What new skills matter most for a Chief Quality & Regulatory Officer?

Increasingly, AI Governance & Ethical AI in Quality and Global Supply Chain Resilience & Geopolitical Risk. These are the skills our record of this role lists as growing.

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17Where to go from here

Other roles at Level 8

Same depth of qualification, different job. Useful if the work appeals but this particular role does not.

 More jobs in compliance, quality and safety

Stay in the field you know and move sideways rather than up.
If you leave this industry

Expertise in enterprise level quality and regulatory governance carries across regulated industries such as pharmaceuticals, medical devices, aerospace, automotive, food and beverage, and energy. The principles of a strong QMS, risk management, and regulatory compliance apply wherever safety and integrity matter.

This role profile is © 2026 Growth Engineering Technologies Ltd. Built from UK occupational standards and regulated qualification data, and written for Zavmo.

You're not behind. You're right on time. The shift is only just beginning. Your role won't look the same in two years. Be the one who leads the change, not the one it happens to. Start my free Automation Fluency module What happens next: a free account, then we build your plan as you set up. No card. Build your plan, see your roadmap and meet the twelve tutors matched to you. All free. When you're ready to start learning, it's £70 a month, billed monthly. Cancel any time and billing stops.