External Supply Quality Lead

We need 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 External Suppliers across a specific region.

Key Responsibilities

• Lead Quality Agreement negotiations with External Suppliers and implement Quality Systems performance management with appropriate KPIs.
• Monitor the quality performance of External Suppliers and drive remedial action where necessary.
• Support technical assessment and perform Quality assessment for new product introductions.
• Partner with External Suppliers and internal teams to assure seamless communication and exceptional quality outcomes.
• Liaise with key contacts at External Suppliers to ensure relevant and applicable outcomes from quality & manufacturing systems.
• Drive periodic review of Quality Systems at External Suppliers.
• Evaluate effectiveness of External Suppliers' Quality Units and systems.
• Actively participate in External Supply Quality Review Meetings.
• Review and respond to External Supplier regulatory inspections.
• Work with External Suppliers to establish effective CAPAs.
• Support or provide on-time disposition of finished product manufactured by External Suppliers.

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.
• 5 years' experience in various Technical and Operational Quality roles.
• Breadth of knowledge and experience applying cGMPs and other regulations/guidance.
• Change Management experience.
• Previous assignment experience promoting or requiring regional perspective desirable.
• Project Management skills.
• GPS exposure.

Preferred Qualifications

• Master's or PhD and at least 6 years' experience AND/OR equivalency in education and experience.
• Demonstrated sense of urgency.
• Breadth in quality systems principles and practical application.
• Good knowledge and demonstrated application of quality and risk management principles and tools.
• Demonstrated sound decision-making process.
• Technical knowledge of multiple dosage forms.
• Demonstrated ability to effectively multi-task.
• Strong Project Management skills and delivery.
• Excellent verbal and written communication skills.
• Strong interpersonal and negotiation skills.
• Strong problem-solving skills.
• Proven ability to work and collaborate in cross-functional teams.
• Demonstrated intercultural skills.
• Excellent written and spoken language skills.
• Demonstrated commercial acumen.
• Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands.
• Capable of working independently.