Product Quality Strategy Lead

**Site Name**: UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper Providence
**Posted Date**: Dec 2 2024

This role sits within the GSK Global Quality function (within the Pharmaceutical Supply Chain) and reports into the Senior Director - Product Quality Strategy.

**Job purpose**:
This role is responsible for quality oversight of product(s) as they transition from clinical trial phase III (commit to) through commercial launch (and into the product life cycle). The position provides quality over-sight and expertise as the product is prepared for commercialisation. In delivering your role you will oversee and manage the Quality Strategy for New Products under late development (starting from phase III) to ensure that the overall Quality, Technical Development, Product Quality Risk, Compliance, and Regulatory considerations are integrated according to GSK Quality goals. To achieve this you will work closely with Research and Development, MSAT, Global QC, CMC leaders and Manufacturing sites (including third-party partner organisations), as well as all relevant regulatory bodies.

**Key Responsibilities (include)**:

- Drive the End-to-End Product Quality of commercial Vaccines and Medicines (for commercial advantage) focusing on proactive product, process, and analytical improvements.
- Establish strategic partnerships with Technical experts (MSAT Molecular Steward, Site Quality Heads, QC Heads), Product Strategy team managers, GRA CMC leads, and RD CMC leads to ensure that Product Quality Strategy is embedded throughout development and commercialization efforts for successful launch, lifecycle management and continued marketing of Vaccines and/or Medicines.
- Chair the Product Quality/CMC Quality Team to ensure alignment on Quality Strategy of the assigned product and ensure One Voice Quality at CMC technical/strategy meetings. Also to represent all Quality Functions at the PTLT/PSLT with responsibility for defining the Product Quality Strategy (PQSt) for commercial Vaccines or Medicines.
- Responsible for Product Quality elements of the RD CMC matrix teams and developing the overall product quality strategy, including Quality oversight of TRA/CPP/PCS, definition of release specification, stability and Shelf-life strategy. Defines and adheres to CMC quality deliverables or milestones that will support NPI acceleration from the commit to Phase III to product launch.
- Ensures quality management of transversal/global changes, deviations and CAPAs associated with the assigned product comply with cGMP standards, extending to product quality risk detection and overseeing actions/mitigation of the risk. Communicating escalation of potential issues and risks to line manager and manage through appropriate governance forum.
- Quality oversight of Product Quality Reviews (PQR) and Manufacturing Robustness Review Boards (MRRB) for the assigned asset.
- Reviews dossiers/ files submitted to health authorities, as well as the approval of regulatory submissions (and support pre-approval inspection readiness). Management/ oversight of post approval changes.
- Provides functional expertise and guidance to their assigned asset(s), communicating project needs to quality functional areas (e.g., external quality, quality assurance, lot release).
- Oversight of process validation, viral safety, sterility assurance and device controls for the aligned products.

**Global remit**: Please note that in this role supports a global community, so flexibility on working hours will be required to attend meetings with colleagues and customer groups (to include USA and Europe time zones).

**Location**:Although the role works from an above-site perspective we are ideally looking for applicants who can be based out of one of the following sites: Barnard Castle (Durham, UK), Ware (Hertfordshire, UK), Upper Providence or Upper Merion (Pennsylvania, USA).

**About You**:
This role is a great opportunity to be instrumental in driving GSK’s quality strategy (in relation to its new products). As this role is multi-faceted and includes liaising with a wide variety of stakeholders (including on-site production/operations teams and senior managers), you must be a motivated person who has strong experience of working in complex technical and/or manufacturing situations. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve and drive performance. You will have a strong continuous improvement mindset and be hands-on in your approach.

**APPLICATION CLOSING DATE - Monday 16th of December 2024 (COB).**

**Basic Qualifications**:

- Proven direct experience in the pharmaceutical manufacturing or R&D late phase clinical-trials.
- Great understanding of the Quality and Regulatory requirement from Process Qualification to lifecycle management.
- Relevant qualifications (eg; degree in Science, Pharmacy, Engineerin