Quality Systems Manager

Talentmark; Burton upon Trent; On-site; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Private Healthcare

Pension Scheme

Life Assurance

Gym Discount

Wellness platforms

Yearly Pay Reviews

Job summary

Talentmark is recruiting a Quality Systems Manager for a site-based, permanent role in Burton upon Trent. You will own and drive the Quality Management System across the aseptic compounding unit, collaborating with operations and quality teams to ensure compliance and continual improvement.

The role requires leadership over audits, CAPA and quality records, with robust investigation capabilities and a focus on reducing variation to support patient safety and regulatory readiness.

Qualifications

• Degree-level qualification in Life Sciences.
• 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.

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.

Skills

Quality Management Systems

GMP Knowledge

CAPA & Nonconformances

Investigation & Problem Solving

Document Control

Audit Management

Education

Degree-level Life Sciences qualification

Job description

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.