Product Quality, Strategy Lead
Location: UK, Ware
Job Purpose
This role is responsible for the quality oversight of product(s) from the commit to phase III to commercial launch and through to product life cycle.
Key Responsibilities
* Responsible for the quality oversight of the product or group of related products from PhIII through to commercial launch, ensuring compliance with appropriate standards.
* Accountable to ensure the quality management of changes, deviations and CAPA comply with cGMP standards.
* Responsible for adhering to quality milestones that will support acceleration from the commit to PhIII to product launch.
* Product quality risk detection and ownership, overseeing actions and mitigation of the risk.
* Responsible for reviewing the dossiers/files submitted to health authorities.
* Responsible for the approval of regulatory submissions and support in pre-approval inspection readiness.
* Responsible for providing functional expertise and guidance to their assigned asset(s), communicating project needs to quality functional areas (e.g., external quality, quality assurance, lot release).
* Responsible for quality element of the CMC matrix team in developing the overall product quality strategy.
* Responsible for communicating/escalating potential issues to line manager and managing through appropriate governance forum.
* Management/oversight of post approval changes.
* Oversight of viral safety, sterility assurance and device controls for the aligned products.
Why You?
Basic Qualifications
* Degree or equivalent in life sciences or related sector.
* Strong base experience working in the pharmaceutical industry with understanding of GMP and standards required for clinical manufacture and release.
* Experience in quality assurance and quality control in an R&D or commercial environment is desirable.
* Demonstrated ability to work across functions.
* Clear communication style - both verbal and written.
Job Application Close Date: 23rd April 2023 #J-18808-Ljbffr