Head of Quality Bard

Head of Quality Bard

Mundipharma

Cambridge, United Kingdom

Role and Responsibilities

To lead the Quality function at the manufacturing site, ensuring compliance with GMP and other applicable regulatory standards. The Site Quality Manager will represent Quality on the Site Leadership Team as the single point of contact for Quality and work closely with the Site Director to ensure that the site is compliant and delivering quality product to patients.

They will provide strategic direction and operational oversight for Quality Control (QC), Stability Testing and Analytical Systems and Services. The role requires close coordination with the QPs, Quality Assurance (QA) and Validation teams.

Quality Leadership & Governance

• Act as the Quality representative on the Site Leadership Team.
• Ensure the site is compliant and inspection ready at all times such that it can deliver quality product to patients.
• Champion and drive a culture of quality and continuous improvement across the site. Lead change in an engaging, collaborative and supportive manner.
• Provide strategic input to the Site LT to ensure alignment with company objectives and regulatory requirements.
• Ensure alignment with global and regional Quality strategies and standards.

Active member of the QLT

• Bring strategic thinking and input to the QLT to ensure that the company is GXP compliant and aligned with company objectives.
• Be an active, engaged member of the QLT.

Compliance & Control

• Ensure site operations comply with GMP, GDP, and other applicable regulations.
• Maintain inspection readiness and lead site responses to internal and external audits.
• Be an active member of Health Authority inspections, collaborating with SMEs to ensure accurate and timely responses.

Cross-Functional Collaboration

• Coordinate closely with QPs, QA and Validation teams to ensure seamless quality oversight.
• Support product release, deviation management, CAPA implementation, and change control processes.
• Facilitate communication and alignment between site and central Quality functions.

Quality Systems & Data Integrity

• Oversee the implementation and maintenance of site-specific quality systems.
• Ensure robust documentation practices and data integrity across all quality operations.
• Monitor quality metrics and report performance to senior leadership.

Team Management

• Lead and develop the QC, Stability Testing, Analytical Systems, and Quality Services teams.
• Set clear objectives, manage performance, and support career development.
• Ensure adequate resourcing, training, and succession planning.

What you’ll bring

• Minimum 8 years in pharmaceutical manufacturing/quality roles.
• Proven leadership experience.
• Demonstrated success in regulatory inspections and managing cross- functional quality interfaces.
• Strong knowledge of GMP, GDP, and regulatory expectations.
• Excellent communication, stakeholder management, and decision-making skills.
• Ability to lead through influence and drive quality culture.
• Strong strategic thinking and risk management skills.
• High attention to detail and analytical capability.
• Leadership and team development skills