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. Working with operations to provide technical service support for process, product, facilities, and cleaning validation, change control, and continued verification essential for GMP and regulatory compliance and continuous improvement objectives. Ensuring robust and compliant validation and change control efforts. Providing leadership and direction to enable the site to meet its business goals by ensuring that laboratory business applications, analytical methodologies, instrumentation, automation, and data management techniques are delivered in a GMP‑compliant manner to meet local and global requirements. Responsibilities Driving all aspects of the Validation Life Cycle and Change Control, ensuring DI requirements are incorporated and maintained. Developing and maintaining the Validation Master Plan to reflect current practices. Defining and optimizing overall product, process, facilities, and cleaning validation strategies, policies, and programs, including change control as developed by the QA department. Strategic planning includes benchmarking against industry trends and continuous improvement against compliance standards and regulations. Managing the development and oversight of validation protocols for all facility services, utilities, equipment, laboratory equipment and systems, including computer systems involved in regulatory processes. Engaging and overseeing analytical test method transfer activities. Managing the development and oversight of the equipment cleaning validation program, including the development of a cleaning validation master plan for each unique process or product; overseeing laboratory equipment validation. Providing validation technical assistance to other GSK organizations when needed and participating in cross‑organizational validation discussions and development efforts. Determining project resource requirements for engineering/validation, including capacity and capability. When required, assessing, appointing, controlling, and directing specific contractors and suppliers. Working with business clients to identify, evaluate, and initiate strategies that deliver business objectives by developing a partnership relationship with the aligned business areas. Collaborating and influencing global/regional service providers to ensure specific business‑justified application requirements are met. Working with business clients, EIS, and other supporting IT areas to provide uninterrupted software, hardware, and network service. Ensuring support processes are in place for laboratory application systems, instrumentation, and automation to maintain the site’s testing and production requirements. Basic Qualifications 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. Preferred Qualifications 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 to 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, listening, and networking skills. Demonstrated initiative and results‑focused problem solving/troubleshooting skills. Good understanding of site business drivers. Proven ability to influence others and foster collaboration. Proven ability to champion change and innovation. Work Model and Location This is a hybrid role requiring regular on‑site presence, with flexibility for remote work as agreed upon with your manager. EEO Statement 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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