Job Description

THE POSITION

The Quality Systems Manager is a leadership role within Quality, responsible for owning and continuously improving the site Quality Management System (QMS) and compliance framework in a highly regulated environment.

The role ensures alignment with global standards and regulatory requirements (including EU GMP, biosafety, and corporate policies), while driving excellence across quality systems, data integrity, supplier quality, and audit readiness.

This is a site-based position in Pirbright, with a minimum of three days per week required on-site, offered on a fixed-term contract until 31 December 2027.

TASKS & RESPONSIBILITIES

Quality Systems Management

• Own and maintain the site Quality Management System (QMS) in line with corporate and regulatory requirements
• Drive harmonization, effectiveness and continuous improvement of quality systems
• Act as Management Representative for relevant systems

Core Quality Processes

• Oversee key QMS processes, including Deviations/CAPA, Change Management, Document & Records Management, Training, Risk Management and Management Review
• Ensure systems remain compliant, effective and continuously improved

Compliance & Audits

• Ensure compliance with GMP, biosafety, HSE and regulatory requirements
• Lead and support audits and inspections, maintaining inspection readiness
• Coordinate audit preparation and hosting

Data Integrity

• Lead the site Data Integrity program and strengthen related controls
• Drive adherence to data integrity standards and lead remediation activities

Supplier Quality

• Oversee Supplier Quality Management, including qualification and audits
• Ensure supplier performance supports production continuity

Projects & Continuous Improvement

• Lead cross-functional projects and continuous improvement initiatives
• Apply structured project management approaches

Leadership & Team Management

• Lead, coach and develop the Quality Systems & Compliance team
• Manage performance, resources and talent development

Stakeholder Collaboration

• Partner with site leadership, QA, operations and global teams
• Collaborate with external stakeholders and ensure alignment with global standards

REQUIREMENTS

Education

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Biology or related field
• Master’s degree preferred

Skills & Experience

• Significant Quality experience within life sciences / regulated environment
• Proven leadership experience, ideally in a matrix organisation
• Strong knowledge of GMP, quality systems and regulatory requirements
• Experience in audit/inspection management and supplier quality
• Solid understanding of Data Integrity principles
• Strong stakeholder management, communication and leadership skills
• Ability to manage multiple priorities in a complex environment
• Analytical mindset with strong problem-solving skills
• High attention to detail, accuracy and accountability
• Good IT skills (e.g. MS Office; quality systems tools an advantage)

WHY THIS IS A GREAT PLACE TO WORK

Boehringer Ingelheim is recognised as a Top Employer in the UK, reflecting our commitment to exceptional workplace standards, career development and a purpose-driven culture. Our employees contribute to meaningful work, creating long-term value for people, animals and the environment.

Learn more about why BI is a great place to work:
https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work

Candidates may be asked to undergo a Basic Disclosure and Barring Service (DBS) Security check. Any offer of employment will be subject to satisfactory DBS certificate.