Aseptic Quality Systems Lead – GMP, Audits & Compliance

Talentmark

Burton upon Trent

On-site

GBP 70,000 - 90,000

Full time

12 days ago

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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

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.

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