This role gives you the chance to operate at a senior level within Quality Assurance, leading oversight of external manufacturing, testing, and logistics partners while shaping quality systems across a broad and complex product portfolio. If you enjoy working at the intersection of technical leadership, regulatory excellence, and cross‑functional influence, this position offers deep exposure, autonomy, and strategic scope.
You'll work with international partners, handle high‑impact quality decisions, and play a critical role in ensuring products are manufactured, tested, released, and distributed in full compliance with global standards.

What You'll Lead & Achieve
Quality Oversight of External Partners

• Provide leadership and oversight of Contract Manufacturing Organisations, Contract Testing Laboratories, and third‑party logistics partners.
• Lead Quality Business Reviews, audits, validation approvals, and stability program oversight.
• Ensure data integrity, method transfer accuracy, and ongoing inspection‑readiness.

Quality Management System Influence

• Strengthen and maintain site quality documentation and systems.
• Lead internal audits, support change controls, deviations, CAPAs, and batch‑related quality processes.
• Own KPI tracking and support cross‑functional teams in meeting high QMS standards.

Product Lifecycle & Technical Quality Activities

• Review and approve validation protocols, reports, sampling strategies, and testing coordination.
• Support artwork approvals and lead high‑complexity investigations.
• Compile and present Product Quality Reviews.

Regulatory Engagement & Recall Readiness

• Provide expert QA input for regulatory notifications.
• Manage recall readiness activities and contribute to licence‑related documentation.

Sample & Record Management

• Own the full Reference and Retain Samples program, including storage, custody, and retrieval standards.
• Oversee archiving for external partners to ensure complete, inspection‑ready product histories.

Training & Leadership Influence

• Write and maintain SOPs, questionnaires, and controlled documentation.
• Deliver training on QA systems, investigations, data integrity, and change control.
• Support management review with insights on QMS performance.

Cross‑Functional Collaboration

• Represent QA during audits, inspections, and partner meetings.
• Maintain strong relationships across internal and external teams.

What This Role Offers You

• Strategic impact across an international network of manufacturing and testing partners.
• High‑level technical engagement in validation, investigations, regulatory input, and lifecycle documentation.
• Leadership visibility through cross‑functional collaboration and representation in audits and reviews.
• Professional growth in advanced QA, external manufacturing oversight, and regulatory readiness.
• Autonomy to manage complex quality systems and drive continuous improvement.

Ideal Background & Skills
You'll thrive if you bring:
Essential

• BSc in a scientific discipline.
• Strong knowledge of pharmaceutical QA, cGMP, quality systems, and analytical chemistry.
• Approximately 10 years' experience in regulated pharmaceutical QA/QC roles.
• High attention to detail, strong organisational skills, and the ability to work independently.

Desirable

• MSc in Quality Assurance.
• Experience managing external manufacturing and contract labs.
• Familiarity with EU GMP/GDP, lifecycle documentation, sampling standards, stability/validation, and data integrity principles (e.g., ALCOA+).
• Proven communication skills for partner and stakeholder engagement.

Who This Role Is Perfect For
Someone who wants to:

• Take ownership of complex, high‑impact quality activities.
• Work closely with global partners while influencing internal systems and processes.
• Lead investigations, manage regulatory interactions, and elevate overall quality performance.
• Build a deeper, more strategic QA career with increasing autonomy and technical depth.

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Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.