Quality Control Direct Director

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h3Quality Control Direct Director /h3pBusiness Introduction /ppGSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. /ppOur diverse portfolio consists of vaccines, specialty medicines, and general medicines. /ppThrough continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges. /ph3Position Summary /h3pThis position oversees Quality Control operations in the Parma Network Laboratory and leads the delivery of analytical testing for the Parma site and the wider Biopharm network. Essential functions include planning and prioritizing resources and laboratory capacity to meet release, stability, validation, analytical method transfer, and development testing requirements for internally and externally manufactured products. The role ensures alignment with the Biopharm analytical network strategy, including effective allocation of testing across Parma and network laboratories, support for new product introductions, and reduction of reliance on third‑party testing where appropriate. /ppThis position is responsible for the dynamic analytical strategy and technical requirements for assay transfer, digital transformation, and collaboration with RD, Global QC, manufacturing sites, external partners, and clients. Other functions include laboratory investigations related to product testing and compiling reports in support of regulatory filings.



The incumbent reviews and releases test results and ensures full cGMP compliance in laboratory operations. The QC Director also reviews regulatory submissions, including INDs, BLAs, and MAAs, and supports internal and external audits, client audits, and regulatory inspections. /ph3Responsibilities /h3ulliResponsible for Analytical and Microbiology testing and release (RM, components, IP, FP), Laboratory investigation and CAPA, Stability testing, Sample and retain management, Microbiology testing, EM and utilities monitoring, and Incoming materials testing. /liliLead and coordinate analytical testing support for the Parma site and the Biopharm network, including release, stability, validation, analytical method transfer, and new-product-introduction testing, while balancing network priorities, laboratory capacity, testing readiness, and supply continuity. /liliProvides in depth technical and scientific advice and guidance to laboratory supervisors and analysts in the Quality Control Laboratory and Operations. /liliLeads and empowers a team of lab leaders to ensure the laboratory is a data factory with analysts and systems that support the sampling, testing, and generation and review of data per ALCOA principles. /liliEnsures that departmental laboratory and manufacturing related investigations are completed in a timely manner.



/liliEnsures that the Quality Control team continues to grow technically and professionally; encourages their development efforts toward excellence and a higher degree of proficiency. /liliProvides leadership by ensuring compliance of the department with laws, regulations, guidelines, procedures, and practices governing analytic Quality Control testing, including the departmental, and company Standard Operating Procedures, and safety procedures. /liliEnsures that processes are in place to ensure that records and technical data were accurately maintained and results well documented. /liliRepresents the Quality Control department and departmental functions on projects/committees within GSK. /liliProvide support of product filings with regulatory agencies (IND, BLA MAA etc) /li /ulh3Qualifications/Skills /h3h3Basic Qualifications: /h3ulliDemonstrated success leading a team comprised of varying levels of technical expertise and functions. /liliDemonstrated success developing teams. /liliStrong verbal and written communication skills. /liliAble to interact with peers, subordinate and senior personnel in multidisciplinary environment including development, engineering, facility operations, validation, production and QA. /liliAble to prioritise and decide appropriate course of actions. Effective at implementing decision. /liliFully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions /li /ulh3Preferred Qualifications: /h3ulliExperience supporting new product introductions, method transfers or technology implementations. /liliExperience with laboratory information systems, electronic lab notebooks or laboratory automation. /liliStrong track record in driving continuous improvement and operational excellence in labs. /liliExperience managing budgets, resource planning and recruitment for laboratory functio /li /ul #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8h1v9j