QA Manager - Cell & Gene Therapy, Open to flexible working
This is an exciting opportunity to be involved in a complex cutting-edge manufacturing and testing programme due to be undertaken by GSK. To thrive in this challenging role, you must be determined and ambitious to succeed. You will have the chance to work with innovative technologies and be part of a high visibility project at GSK.
- Provide input into the development of strategy, policy, group objectives and processes in Product Quality Pharma R&D and with business partners, specifically with respect to Cell and Gene Therapy QC, Third Party Management, Analytics, Specifications.
- Assure products meet regulatory requirements and that they conform to regulatory submissions. Specifically, managing the licensure of the Stevenage QC laboratory and assuring compliance.
- Interact with regulators and/or industry experts to represent GSK interests, especially for the Stevenage QC labs, third party labs, third party Vector manufacturing, etc.
- Interpret and apply regulations/policies to unique and often complex issues related to Cell and Gene Therapies.
- Manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
- Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.
- Lead a project, program or team activities which may include GxP.
- Contribute to an environment that optimizes employee productivity and adds value.
- Develop group skill sets and knowledge base to meet the needs of a changing environment.
- Direct the activities of one or more direct reports or lead a matrix team or business process.
- Actively engage in risk management activities to identify effective risk management strategies including the escalation of risks and their solutions.
- Act as a coach, mentor or trainer to develop others.
- Represent the group as a business contact or on a quality forum/council.
- Proactively identify, communicate and monitor business/regulatory changes that could impact on quality or compliance across Pharma R&D.
- Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers.
- Communicate and interact at various levels internally and externally to GSK.
- Develop internal/external networks to communicate with key stakeholders.
- Engage with the business in strategic/operational decisions on behalf of the group.
Specific Accountabilities that may be performed based on training:
- Approve GMP documentation, including Standard Operating Procedures validation documentation, change controls and other controlled documents from business partner areas.
- Approve Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
- Manage internal assessment schedule and ensure compliance.
- Approve investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
- Approve GxP training for delivery to business partners.
- Ensure 3rd party management activities, including audit of suppliers and contract resource organizations, are performed utilizing third party assessment procedures.
- Initiation and maintenance of Quality Assurance Agreements
- Conduct review of completed Vector, Drug Product and QC laboratory records.
- Perform Plasmid, cell bank and Vector release activities (global)
- QP certification of drug product, if eligible
- Degree qualified in science based subject or equivalent experience
- Experience in Cell and gene therapy or Cell Biology
- Quality Assurance experience
- Quality Control Analyst experience
Skills of Interest:
- Experience of QA roles e.g., Audit, Deviation, Data integrity, Change Control, Equipment Validation, Regulatory Inspection experience, Third Party Oversight
- Qualified person (QP)
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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