Quality Systems & Compliance Manager

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

Burton on Trent, Staffordshire, United Kingdom

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.

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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