Quality Systems Lead: Aseptic Compliance & Audit

Sciensus; Burton upon Trent; On-site; GBP 60,000 - 80,000; Full time

Benefits offered by this job

25 days annual leave

Life Assurance

Pension scheme

Private medical

Job summary

Sciensus seeks a Quality Systems & Compliance Lead for its aseptic compounding unit. You will own the Quality Management System, ensuring GMP/GDP compliance and audit readiness to support safe patient outcomes.

Responsibilities include leading document control, QA data management, KPI reporting, CAPA investigations, and internal/external audits, with a focus on reducing variation and driving continuous improvement in a regulated environment.

Qualifications

• Strong knowledge of Quality System processes.
• Working knowledge of EU/UK GMP.
• Experience in Document Control, Internal Audit, CAPA, Nonconformance and Complaints processes.

Responsibilities

• Lead QA data review, KPI reporting, and audit responses.
• Drive risk management and trend quality data to ensure timely actions.
• Own the Quality Management System and regulatory compliance.

Skills

Quality systems

GMP/GDP

Audit management

CAPA

Document control

Regulatory coordination

Problem solving

Education

Life sciences degree

Tools

Audit management software

CAPA tracking system

Job description

Sciensus seeks a Quality Systems & Compliance Lead for its aseptic compounding unit. You will own the Quality Management System, ensuring GMP/GDP compliance and audit readiness to support safe patient outcomes.

Responsibilities include leading document control, QA data management, KPI reporting, CAPA investigations, and internal/external audits, with a focus on reducing variation and driving continuous improvement in a regulated environment.