Quality Systems Manager

Quality Systems Manager

Burton upon Trent | Site-Based | Permanent

Talentmark is delighted to be recruiting for an established pharmaceutical manufacturer seeking an experienced Quality Systems Manager to lead the Quality Systems & Compliance function within its aseptic compounding unit.

This is a key leadership role with responsibility for the site Quality Management System (QMS), ensuring robust processes, strong compliance and a culture of continuous improvement. You'll play a vital role in reducing variation and ensuring the site remains GMP/GDP compliant and audit-ready, ultimately supporting safe patient outcomes.

The Role

You’ll take ownership of the Quality Management System and provide oversight across key quality processes, working closely with operational and quality teams.

Responsibilities:

• Owning and maintaining the QMS, ensuring it remains effective and compliant.
• Managing document and data control, including review and approval of controlled documentation and quality records.
• Monitoring and reporting quality KPIs, trends and performance to the Aseptic Compounding Management Team.
• Overseeing CAPAs, complaints, deviations, nonconformances and quality risk management.
• Leading internal audits and coordinating responses to external, regulatory and customer audits.
• Driving effective investigations and ensuring corrective actions are delivered promptly.
• Identifying opportunities to improve processes, reduce variation and strengthen quality performance.

Your Background:

• Degree-level qualification in a relevant Life Sciences discipline.
• Strong knowledge of Quality Management Systems and processes.
• Working knowledge of EU/UK GMP.
• Experience across Document Control, Internal Audit, CAPA, Nonconformance and Complaints.
• Strong investigation and problem-solving skills, with experience using tools such as 8D, 5 Whys, Cause & Effect or Gemba.
• Experience within pharmaceuticals, medical devices, biotechnology, microbiology regulated industries.

This is an excellent opportunity to take a leading role in shaping quality culture and compliance within an aseptic compounding environment, with the opportunity to make improvements that directly support patient safety and clinical outcomes.

Benefits:

• Private Healthcare cover.
• Company Pension Scheme.
• Life Assurance.
• Gym Discount.
• Access to Wellness platforms.
• Yearly Pay Reviews.

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