This is an opportunity to lead the Quality Systems & Compliance function for our aseptic compounding unit – driving high standards, removing waste, reducing variation and ensuring we are always audit‑ready.
You’ll be the owner of our Quality Management System, ensuring we meet regulatory expectations, uphold GMP/GDP standards and maintain robust, reliable processes that support safe patient outcomes.
Day to day tasks
Document & Data Management
- Ensure all controlled documentation is current, accurate, relevant and accessible.
- Review and approve new/updated procedures and quality documentation.
- Ensure quality records are complete, legible and compliant with good documentation practice.
Quality System Oversight
- Report monthly quality KPIs to the Aseptic Compounding Management Team.
- Review QA data, quality documentation, and compile reports.
- Ensure quality data (including CAPA, Complaints, deviations, etc.) is tracked, trended and monitored for timely completion.
- Champion risk identification and management across the unit.
Audit Management
- Lead internal audits and coordinate responses to external, regulatory and customer audits.
- Drive investigation of audit findings and ensure corrective actions are delivered promptly and effectively.
This is a full‑time, site‑based role working 40hrs per week.
Who we’re looking for
A quality leader with strong systems knowledge. You’re someone who thrives in a regulated environment, can manage multiple workstreams and enjoys collaborating with teams to solve problems and improve processes.
Qualifications
- Strong knowledge of Quality System processes
- Working knowledge of EU/UK GMP
- Experience in Document Control, Internal Audit, CAPA, Nonconformance and Complaints processes
- Problem‑solving tools such as 8D, GEMBA, 5 Whys, Cause & Effect
- Strong communication, coordination and people management abilities.
- High attention to detail, strong organisational skills and a proactive, motivated mindset.
- Strong problem solving and investigation skills.
- Effective team player who can manage a broad workload.
Preferred qualifications
- Degree‑level qualification in a relevant Life Sciences discipline
- Experience in quality facilitation, project management, process improvement or quality data analysis.
- Experience in pharmaceuticals, medical devices, biotechnology, chemistry, microbiology or similar regulated industries.
What’s in it for you
- A key leadership role shaping quality culture across our aseptic compounding unit.
- The chance to improve systems that directly impact patient safety and clinical outcomes.
- Opportunities for professional growth and development within a regulated, complex and meaningful environment.
- Working alongside highly skilled colleagues who share your commitment to excellence.
Benefits
- 25 days annual leave & bank holidays
- Yearly pay reviews
- Over‑time rates
- Annual company event
- Refer a friend scheme
- Contribution based pension scheme
- Life Assurance
- Bike to work scheme
- Discount & cashback portal
- Private medical after two years’ service
- Internal & External training opportunities
- Paid volunteer day
Equal Opportunity Statement
Sciensus is a place that values difference and promotes respect. We are committed to the fair treatment of all candidates and actively promote equality for all and select interviewees based on skills, qualifications, and experience. Sciensus takes equal opportunities and improving the working lives of our colleagues seriously. We also support with any reasonable adjustments required. Please talk to us during the application process to discuss any reasonable adjustments you may require.
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