One of our valued Rare Disease Pharmaceutical clients looking for a GCP Drug Development Quality Manager to join the clinical operations team and ensure the smooth running of development projects and QA strategy across multiple functions.
The role requires a GCP SME and strong day-to-day quality leader for development projects, taking ownership of QA strategy across pre‑clinical, clinical and regulatory activities. You would build and maintain processes to transfer products smoothly from development to commercial launch, whilst providing supplier and CRO quality oversight, leading audits, managing quality agreements, and holding external partners to organisational standards.
You’ll work across multiple therapeutic areas, collaborate with internal teams across the business, and play a key role in strengthening quality systems to support continued growth and unwavering focus on patient safety.
Key Responsibilities
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Serve as Quality Lead for development programs, driving QA strategy across pre-clinical, clinical, and regulatory phases.
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Partner with cross-functional product development teams to ensure full compliance with quality and regulatory requirements.
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Develop and implement robust processes to enable seamless transition from development through commercial launch.
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Provide supplier and CRO quality oversight, including leading audits and managing quality agreements.
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Act as the Quality representative on cross-functional initiatives, delivering GCP expertise and training.
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Proactively identify risks, resolve complex quality challenges, and enhance operational quality systems.
Key Skills & Experience
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BSc or MSc in Life Sciences or related scientific discipline.
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Extensive Quality Assurance experience supporting clinical drug development within Pharma or Life Sciences.
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Strong working knowledge of GxP and GCP requirements across all phases of clinical development.
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Excellent written and verbal communication skills with the ability to engage diverse stakeholders.
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Detail-oriented with strong analytical and problem-solving capabilities.
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Confident influencer with strong stakeholder management skills and the ability to challenge constructively.
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Highly organized, dependable, and accountable for deliverables.
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Demonstrated commitment to compliance, quality excellence, and continuous improvement.
Benefits:
In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:
- Competitive salary
- Flex working – Start earlier, finish earlier and vice versa.
- A collaborative high performing work environment
- Performance based bonus
- Opportunity to join a fast growing and ambitious business
- Company pension scheme
- 100% employer paid membership for Private Health Insurance
- Life and Critical Illness Insurance
- Corporate Gym membership
- Regular team building events and an agile working environment
If you're an ambitious quality specialist with strong clinical GCP experience and ready for a new opportunity, please send us through an updated resume. Alternatively you can call Freya Peniston-Bird on 020 7959 4302 for further details.
Need more help? Reach out<br></br> to one of our team.
We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.
