Director, Quality

JR United Kingdom; Cambridge; On-site; GBP 60,000 - 100,000; Full time

Job summary

An innovative clinical-stage biotech is seeking a Director of Quality with extensive GCP experience. This role offers the chance to lead a dedicated QA team, shape quality systems, and ensure inspection readiness in a fast-paced environment. You will be pivotal in driving strategy across global clinical programs and embedding a quality-first culture. If you are a strategic thinker and a hands-on leader ready to make a significant impact in the biotech field, this opportunity is perfect for you. Join a passionate team as they approach a major BLA submission and help shape the future of healthcare.

Qualifications

• 10+ years in Clinical Quality Assurance with GCP expertise.
• Strong leadership experience in managing teams and strategy.

Responsibilities

• Lead the GCP Quality team, overseeing strategy and execution.
• Ensure inspection readiness and represent QA in global audits.

Skills

GCP Expertise

Clinical Quality Assurance

Leadership

Regulatory Knowledge (US, EU, UK)

Risk Management

Education

Bachelor's degree in life sciences

Advanced degree

Tools

GMP

Audit Management

Job description

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George Higginson is currently searching for an experienced Director, Quality (GCP), with over a decade of experience in GCP, preferably across Ph. II and Ph. III, with an-and-coming clinical-stage Biotech, developing a ground-breaking nanobody for Inflammatory Diseases.

We’re looking for a true leader in GCP Quality to drive strategy and oversight across global clinical programs through Phase II, Phase III, and into commercialisation. You’ll head up a growing QA team and play a key role in shaping quality systems and ensuring inspection readiness in a fast-paced biotech environment.

Main Responsibilities:

• Lead and develop the GCP Quality team, overseeing strategy, execution, and continuous improvement.
• Define and implement GCP Quality oversight across internal functions and external partners.
• Ensure inspection readiness and represent QA in global audits (FDA, EMA, MHRA).
• Advise on clinical compliance, risk management, and quality system development.
• Partner with senior stakeholders to embed a quality-first culture across clinical programs.

Requirements:

• 10+ years of Clinical Quality Assurance experience with deep GCP expertise across Phase 2 and 3 trials.
• Strong leadership background, with proven experience managing teams and driving strategy.
• Global regulatory knowledge (US, EU, UK) and hands-on inspection/audit experience.
• Experience in risk-based audit planning, vendor oversight, and quality performance monitoring.
• Bachelor’s degree in life sciences required; advanced degree preferred.

Bonus Points For:

• Experience with GMP as applied to clinical development.
• Background in Biologics.
• Involvement in BLA or MAA submissions.

What We’re Looking For:

• A strategic thinker and hands-on leader.
• Someone who leads by example, motivates teams, and thrives in a dynamic, agile environment.
• A communicator who can influence at all levels, internally and externally.

This is a fantastic opportunity to be a key part of a true-underdog clinical-stage Biotech, soon approaching a BLA submission.

Apply today to take the next step in your leadership journey!