Morgan Prestwich - Life Science & Healthcare Executive Search
Quality Assurance Manager
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Role Overview
This role offers the opportunity to join an exciting and ambitious biotech where you'll have an opportunity to develop and strengthen their quality function implementing robust quality systems and ensuring compliance across development and external partner activities.
Working across internal teams and external partners, you'll drive quality oversight of outsourced activities, strengthen compliance and help embed a culture of continuous improvement as the company progresses through clinical development.
Responsibilities
- Serve as the GxP quality lead, providing expert guidance across the business.
- Develop, maintain and enhance the Quality Management System (QMS) and related processes.
- Monitor quality performance through metrics, risk management and continuous improvement initiatives.
- Oversee quality activities across CDMOs, CROs and suppliers, including qualification, Quality Agreements and performance reviews.
- Manage deviations, CAPAs, change controls and quality risk assessments.
- Lead inspection readiness and support regulatory inspections from preparation through to follow-up.
- Plan and conduct internal and supplier audits to ensure compliance with GMP, ICH and other applicable regulations.
- Review and approve key quality documentation and GxP records.
- Support product release activities and provide quality oversight throughout the development lifecycle.
- Represent Quality Assurance on cross-functional projects, working closely with CMC, Regulatory Affairs, Clinical Operations and external partners.
- Champion a culture of quality, compliance and continuous improvement.
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Essential Requirements
- Degree in a scientific discipline or equivalent industry experience.
- Proven Quality Assurance experience within the pharmaceutical or biotechnology sector.
- Strong knowledge of GMP, GCP, ICH guidelines and pharmaceutical quality systems.
- Experience developing or enhancing Quality Management Systems (QMS).
- Background overseeing outsourced manufacturing, development or testing activities.
- Experience managing supplier qualification, audits and Quality Agreements.
- Hands-on experience with deviations, CAPAs, change controls and quality risk management.
- Proficient with eQMS and electronic document management systems.
- Strong communication, organisational and problem-solving skills, with the ability to work independently in a fast-paced environment.
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Desirable Requirements
- Experience within a clinical-stage or emerging biotech environment.
- Exposure to regulatory inspections, submissions and interactions with health authorities.
- Experience supporting clinical development programmes, including IMPs.
- Knowledge of risk-based quality management principles (e.g. ICH Q9).
- Experience with biologics and/or advanced therapy medicinal products (ATMPs).
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