External Supply Quality Lead

**Site Name**: Mississauga Milverton Drive
**Posted Date**: Jan 24 2025

Are you passionate about ensuring product quality, compliance, and reputation at the global level? Join us as an External Supply Quality Lead in our #Mississauga office. In this #hybrid position, you’ll play a pivotal role in safeguarding GSK’s standards by managing critical relationships with our External Suppliers across a specific region. In this dynamic position, you’ll be the key liaison, building and maintaining strong, collaborative connections with multiple stakeholders, from Quality and Regulatory teams to Production and Site Management. You’ll also work closely with internal teams, including External Supply, Procurement, and Technical departments, to ensure seamless communication and exceptional quality outcomes. If you're ready to take on a challenging, impactful role where your expertise will directly contribute to GSK’s success, we want to hear from you
- This is an 18-month contract, an excellent way to get your foot in the door

**Posting expires on February 4, 2025 at 23:59 EST

Key Responsibilities
- Lead Quality Agreement negotiations with External Suppliers and implement Quality Systems performance management with appropriate KPIs based on contractual parameters. Ensure regulatory compliance is managed through flow of regulatory information to and from the releasing Sites as governed by Quality Agreements.
- Support technical assessment and perform Quality assessment for new product introductions. Review and approve significant documentation associated with the introduction or transfer of a new or existing product to External Suppliers, including regulatory documents. Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internals specifications, master batch records and others as needed.
- Partner with External Suppliers and ES Procurement, Quality, Technical and Supply (PQTS+) to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product.
- Liaise with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance. Provide specific GMP training for contractors, where deemed necessary. Review and disposition batch records when responsibility falls within EQ.
- Drive periodic review of Quality Systems at the External Suppliers, to complement audit processes. Where required, support the External Supplier by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions.
- Evaluate effectiveness of the External Supplier’s Quality Unit and systems and influence External Suppliers promoting robust systems operating under self-sufficient organizations. Escalate serious cGMP/Regulatory compliance issues following internal procedures. Support efforts that positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly distributed for incorporation in local action plans.
- Actively participate on the External Supply Quality Review Meetings, identifying Quality related issues and continuous improvement opportunities, with proposals to address these.
- Review and respond to External Supplier regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspections and External Supplier responses to Regulatory observations prior to submission to the associated agency.
- Work with External Suppliers to establish effective CAPAs, in response to GSK audit observations and ensure the Suppliers manage these to acceptable closure. Ensure timely communication of Quality Alert
- Support or in some regions provide on time disposition of finished product manufactured by External Suppliers to meet supply chain demand.

Basic Qualifications
- Degree in a Science or related discipline and at least 8 years experience in a Pharmaceutical company
- Broad experience of cGMP and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processes
- 8 years' experience in various Technical and Operational Quality roles.
- Change Management experience.
- Previous assignment experience promoting or requiring regional perspective desirable.
- Project Management skills.
- GPS exposure.

Preferred Qualifications
- Masters or PhD and at least 6 years experience AND/OR equivalency in education and experience would be an asset.
- Demonstrated sense of urgency.
- Technical knowledge of multiple dosage forms.
- Demonstrated ability to effectively multi-task.
- Strong Project Management skills and delivery.
- Excel