Quality Technical and Validation Manager

Position Summary

Ensuring that the facilities, equipment, systems, and processes used in the manufacture and testing of pharmaceuticals have been appropriately validated and maintained in a validated state. Organizing and directing all validation activities, including capital projects, and working with operations to provide technical service support for process, product, facilities, and cleaning validation, change control, and continued verification. Maintaining robust and compliant validation and change control efforts and providing leadership to enable the site to meet its business goals by ensuring laboratory business applications, analytical methodologies, instrumentation, automation, and data management techniques are delivered in a GMP‑compliant manner.

• Drive all aspects of the Validation Life Cycle and Change Control while ensuring DI requirements are incorporated and maintained.
• Develop and maintain the Validation Master Plan, reflecting current practices.
• Define and optimize overall product, process, facilities, and cleaning validation strategies, policies, and programs, including benchmarking against industry trends and continuous improvement.
• Manage the development and oversight of validation protocols for all facility services, utilities, equipment, laboratory equipment, and systems, including computer systems involved in regulatory processes.
• Engage and oversee analytical test method transfer activities.
• Develop and oversee the equipment cleaning validation program, including a cleaning validation master plan for each unique process or product.
• Oversee laboratory equipment validation and provide technical assistance to other GSK organizations when needed.
• Participate in cross‑organizational validation discussions and development efforts.
• Determine project resource requirements for engineering and validation, including capacity and capability.
• Assess, appoint, control, and direct specific contractors and suppliers as required.
• Work with business clients to identify, evaluate, and initiate strategies to deliver business objectives, developing partnership relationships with aligned business areas.
• Collaborate and influence global/regional service providers to ensure application requirements are met.
• Provide uninterrupted software, hardware, and network service with business clients, EIS, and other supporting IT areas.
• Maintain support processes for laboratory application systems, instrumentation, and automation to meet the site’s testing and production requirements.

• Bachelor’s degree (BS) or equivalent in Chemistry, Engineering, Quality, Pharmaceutical Operations, or a related field.
• Minimum 10 years of experience in the pharmaceutical industry (15 years preferred).
• Minimum 7 years of validation experience in manufacturing or development (10 years preferred).
• Experience with analytical equipment and analytical method validation.
• Proven experience managing validation projects, including capital projects.
• Experience leading validation teams or high‑paced operational/quality‑focused teams.
• Background in laboratory operations, laboratory applications, or IT within a scientific environment.
• Strong technical expertise in chemical theory, analytical methodologies, laboratory and microbiological instrumentation, and computer applications related to pharmaceutical analysis.

• Strong foundational understanding of departmental resourcing and technical concepts.
• Demonstrated knowledge and core competencies gained through relevant academic programs.
• Strong analytical skills to identify business requirements and provide solutions to complex issues.
• Working knowledge of cGMP regulations, including process validation/product characterization guidelines.
• Analytical validation and transfer expertise.
• Ability to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, engineering, regulatory, and operational disciplines.
• Capability to provide direct supervision in a team‑oriented atmosphere.
• GPS training or equivalent preferred.
• Excellent written and verbal communication, presentation, report‑writing, influencing,…