Validation Manager

Work Schedule

Environmental Conditions

Job Description

Job Title: Validation Manager

Location: Horsham

Position Summary:

Step into an exciting and dynamic role as the QA Validation Manager, a crucial member of the Site Quality Management Team at Thermo Fisher Scientific Horsham. With our global expansion and Horsham evolving from a clinical site to the hub of significant commercial investment, this position offers unparalleled visibility and empowerment. As the QA Validation Manager, you will lead a dedicated team to qualify primary and secondary packaging lines, equipment, processes, and utilities, ensuring top-tier compliance and an exceptional quality system.

Join us at a time of substantial growth, with exciting investments in fully automated commercial packaging, advanced sub-zero storage and sampling facilities, and enhanced clinical packaging and assembly. This is your opportunity to make a significant impact and drive excellence in a thriving global enterprise.

Location / Division Specific Information

This role sits in the Fisher Clinical Services group and is based in Horsham, UK. This is primarily a site-based role with scope for some flexibility.

How will you make an impact?

The QA Validation Manager role leads a diverse team of QA professionals and reports to the Senior Quality Assurance Manager. As part of the Site Quality Management Team, this position is responsible for collaborating with site operational areas and company clients, providing real-time support and maintenance of quality standards.

Key Responsibilities:

• Inspire and Develop: Lead and cultivate a diverse team of QA professionals, promoting cross-skilling and fostering an inclusive environment to ensure the smooth operation of the team.
• Ongoing Support: Lead routine requalification and new validation activities in line with the Validation Policy and Site Validation Master Plan. Own and implement validation procedures and projects according to cGMP and regulatory requirements. Manage quality control processes and equipment maintenance systems.
• Collaborate, Innovate, and Improve: Work closely with other departments to improve validation processes and ensure regulatory compliance. Investigate, develop, and implement enhancements to validation procedures.
• Expert Representation and Advice: Advise on validation requirements to maintain GMP and regulatory compliance across the site. Serve as the Qualification and Validation SME during client audits and regulatory inspections.
• Quality Leadership: Join the Senior Quality Management Team to guide and focus the larger team, ensuring cohesive direction. Chair Site Validation Committee meetings, driving key decisions and strategies.
• Strategic Budgeting: Propose and manage Revenue and Capital Budgets to implement the validation program within agreed limits.
• Performance Measurement: Track, trend, and report on all validation, qualification, and change control metrics monthly and quarterly for management reviews.
• Versatile Responsibilities: Undertake additional duties as directed, supporting the Senior QA Manager and acting as delegate when required to maintain effective site operations.

Join us in this pivotal role and make a significant impact on our expanding global operations, driving excellence and innovation in quality assurance and validation

Minimum Requirements/Qualifications:

• Extensive knowledge of cGMP environments gained within the pharmaceutical industry or related.
• Proven quality assurance experience is a requirement, preferably with a strong knowledge of the validation lifecycle.
• Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction.
• Good, demonstratable interpersonal skills both internally and externally.
• Experience gained at a middle management level within a pharmaceutical environment or related industry.
• Ability to influence across local functions, ThermoFisher sites and clients to achieve objectives.
• Able to analyse problems and define solutions.  Process analytical skills suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit.

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