Director, Quality

AL Solutions; Cambridge; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Director of Quality with extensive GCP experience to lead their growing QA team. This pivotal role involves driving strategy and oversight for global clinical programs, ensuring compliance and inspection readiness in a dynamic biotech environment. The ideal candidate will possess strong leadership skills and a deep understanding of regulatory requirements across multiple regions. Join this innovative firm and contribute to groundbreaking developments in inflammatory disease treatments while fostering a quality-first culture across clinical programs.

Qualifications

• 10+ years of Clinical Quality Assurance experience with deep GCP expertise.
• Strong leadership background with proven experience managing teams.

Responsibilities

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

Skills

GCP Expertise

Leadership

Global Regulatory Knowledge

Risk Management

Quality System Development

Education

Bachelor's degree in life sciences

Advanced degree

Job description

Expert in linking Biometrics, Biologics, and CMC Professionals to Biotech and CDMOs throughout the United States and Canada.

Position: Director, Quality (GCP)

Location: Cambridge, United Kingdom

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 emerging clinical-stage Biotech developing a groundbreaking 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 commercialization. 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; an advanced degree is 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!

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance, Management, and Science

Industries

• Staffing and Recruiting, Biotechnology Research, and Pharmaceutical Manufacturing