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External Quality Lead
GSKExternal Quality Drug Product Lead driving Quality Management System improvement and simplification for GSK’s external suppliers. Overseeing compliance with quality and regulatory standards in manufacturing processes.
Tech Stack
Tools & technologiesC++
About the role
Key responsibilities & impact- Support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met.
- Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met.
- Support collection, monitoring and analysis of quality performance indicators of the External Suppliers using quality standards and tools in place to identify/escalate emerging/developing trends.
- Partner 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.
- Support quality and regulatory compliance.
- Support compliance with QMS and cGMP requirements of external supplier via GMP Audit process.
- Supports risk identification and mitigation process of external supplier and escalate as necessary.
- Engage with External Supplier key contacts 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.
- Support maintenance of Quality Agreement Part A and Bs and TTS.
- Assist External Suppliers with inspection preparedness planning including identification and development of storyboards.
- Report and support resolution of cGMP/Regulatory compliance issues.
- Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate, Legalized and Notarized Declarations and documents as required by for LOCs.
- Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
- Seek clarification on Roles and Responsibilities to ensure team alignment.
- Complete role-based training as assigned.
- Communicate on an ongoing basis with the Quality Managers/Directors to ensure that potential quality issues are identified and that the support is provided to resolve with appropriate sense of urgency.
Requirements
What you’ll need- Bachelor’s degree in pharmacy, Science, or an engineering discipline.
- 5+ years of Manufacturing/Quality experience in the pharmaceutical industry.
- Experience with the application of Quality Systems in manufacturing, warehousing and distribution.
Benefits
Comp & perks- GSK US Benefits Summary available to learn more about the comprehensive benefits program GSK offers US employees.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMPQuality SystemscGMPChange ControlsValidationsAnnual Product Reviewsbatch recordsdeviations investigationsrisk identificationinspection preparedness
Soft Skills
relationship buildinginfluencecommunicationcollaborationproblem-solvingteam alignmenttrustsupportmonitoringanalysis
Certifications
Bachelor’s degree in pharmacyBachelor’s degree in ScienceBachelor’s degree in engineering