Aseptic Quality Systems & Compliance Lead

Sciensus Pharma Services Limited; Burton upon Trent; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

25 days annual leave

Bank holidays

Yearly pay reviews

Over-time rates

Annual company event

Refer a friend scheme

Pension scheme

Life Assurance

Bike to work scheme

Discount & cashback portal

Private medical after 2 years

Training opportunities

Volunteer day

Job summary

Sciensus is seeking a Quality Systems & Compliance leader for our aseptic compounding unit. You will drive quality governance, oversight of documentation, CAPA and audits, and lead improvements to ensure patient safety and audit readiness.

The role is full-time, site-based, and requires strong GMP knowledge, regulatory awareness and leadership across teams. You will shape quality culture and deliver robust processes.

Qualifications

• Degree-level qualification in a Life Sciences discipline or equivalent with regulated industry experience.
• Experience in pharmaceuticals, medical devices, biotechnology or similar regulated fields.
• Strong knowledge of quality systems and compliance in a GMP environment.

Responsibilities

• Lead the Quality Systems & Compliance function for the aseptic compounding unit.
• Oversee document management, approvals and currentness of quality records.
• Review QA data, CAPA, complaints and deviations; drive timely actions.
• Coordinate internal audits and responses to external/regulatory audits.
• Report monthly quality KPIs to management; track data and trends.
• Champion risk management and continuous improvement across the unit.

Skills

Quality System processes

EU/UK GMP

Document Control

Internal Audit

CAPA

Nonconformance

Complaints handling

Root cause analysis

8D / GEMBA / 5 Whys

Communication & leadership

Education

Degree in Life Sciences or related field

Job description

Sciensus is seeking a Quality Systems & Compliance leader for our aseptic compounding unit. You will drive quality governance, oversight of documentation, CAPA and audits, and lead improvements to ensure patient safety and audit readiness.

The role is full-time, site-based, and requires strong GMP knowledge, regulatory awareness and leadership across teams. You will shape quality culture and deliver robust processes.