The Quality Technical and Validation Lead ensures GxP compliance in validating and qualifying processes, equipment, facilities, utilities, software, and systems across manufacturing and analytical areas. It oversees new product introductions (NPI) and supports associated manufacturing and analytical activities to enable smooth product transfers between supply nodes.
Responsibilities
* GxP (Good Practice) Oversight of Validation and Qualification Activities. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, software, utilities and facilities.
* Manage the development and implementation of a validation maintenance program which periodically reviews the status of validated systems and ensures their adherence for the production and laboratory value streams.
* New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with GSK and regulatory standards. This includes review and approval of process and analytical tech transfer tasks, procedures and protocols.
* Work with enterprise partners (Research & Development (R&D), global MSAT (Manufacturing Science and Technology)/validation, Product Quality Leads) in identifying, evaluating and initiating strategies to rapidly develop product transfers by developing a partnership with the business areas to which they are aligned.
* Review and approve validation protocols for facility services, utilities, equipment, software, and laboratory systems; lead the validation team in supporting computer system validation and data integrity requirements.
* Oversee the cleaning validation program, including the master plan and ongoing validation maintenance.
* Assess, review, and approve change control activities related to validation and qualification.
* Ensure laboratory business applications and automation continue to meet testing and production needs during system changes.
* Support Pre‑Approval Inspections (PAI) and routine regulatory inspections as a topic lead or host.
* Provide Quality oversight for GxP engineering activities, including facilities, utilities, maintenance, and local product/process robustness investigations.
Qualifications
* This role offers an on‑site (weekly 5 days) working model at Ware, Hertfordshire, UK. Remote or fully home‑working arrangements are not available.
* Bachelor's degree in Chemistry, Biology, engineering, or a related discipline.
* Experience in the pharmaceutical industry.
* Experience in Process Lifecycle Management activities.
* Experience working for quality operations.
* Experience using analytical equipment and performing method validation.
* Experience applying cGMP regulations, including process validation and product characterization guidelines.
* Experience applying leadership expectations by setting team priorities, coordinating workflow to maintain focus, carrying out defined development activities such as coaching or feedback sessions, practicing self‑awareness in daily interactions, and using agile and culturally adaptable approaches when managing tasks or projects. (Team size 8‑10)
* Experience in performing analytical validation and transfer.
* GPS (GSK Production System) training or equivalent preferred.
* Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, engineering, regulatory, and operational disciplines.
* Capable of providing direct supervision in a team‑oriented atmosphere.
* Experience in communication, presentation, report writing, influencing, listening, and networking.
* Experience applying initiative in problem solving and troubleshooting.
* Knowledge of site business drivers.
* Experience influencing others, supporting collaboration, and contributing to change and innovation.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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