Quality Systems & Compliance Manager

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

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’re always auditready.

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 will consist of:

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.

To be successful within this role we are looking for someone with:

• 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.

Ideally you will hold:

Degree-level qualification in a relevant Life Sciences discipline or

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.

Who we are?

Sciensus is a life sciences business specialising in patient access, engagement and insight solutions. We provide healthcare to patients with long-term conditions, rare diseases and cancer.

For 30 years, we’ve supported patients to access the life‑changing treatment they need, in the comfort and convenience of their own homes across the UK and Europe. Today, we combine our clinical experience from over 70 million patient interactions with the latest technology to help over 200,000 patients a year make the most of their medicine.

So, using unparalleled insights, we connect with people powerfully and personally, focusing on their unique needs, empowering them to achieve their goals, and supporting them every step of the way.

What we offer our people?

We work hard to make sure colleagues feel motivated, developed, and recognised for the great work they do.

Offering a competitive salary and benefits package, this role will allow you to expand your knowledge and expertise with quality standards.

• 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

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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