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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