Third Party Quality Specialist

Role Overview:

The Quality Lead will provide quality oversight for external manufacturing organizations and service providers supporting GMP manufacturing activities for pharmaceutical R&D programs, including API, cell banking, drug substance, and drug product.

Key Responsibilities:

• Serve as the primary quality contact for assigned third-party manufacturers, suppliers, and external service providers.
• Ensure compliance with cGMP, regulatory requirements, GSK quality standards, and established quality agreements.
• Monitor third-party quality performance, compliance status, and overall quality system effectiveness.
• Review and assess GMP documentation, including batch records, laboratory records, validation documents, and manufacturing records.
• Manage and support quality system activities, including deviations, investigations, complaints, change controls, CAPAs, and root-cause analysis.
• Draft, review, maintain, and coordinate the approval of quality agreements and other quality-related documentation.
• Identify, evaluate, document, and escalate quality risks and compliance issues using appropriate risk management processes.
• Support batch documentation review, disposition, and release activities within the scope of assigned responsibilities.
• Coordinate quality governance meetings, track action items, and ensure timely resolution of outstanding quality issues.
• Participate in third-party qualification, supplier approval, audit preparation, audit execution, and CAPA follow-up activities.
• Provide quality support for technology transfers, product transfers, and external manufacturing activities across the R&D lifecycle.
• Ensure proper documentation management, record retention, and archiving in accordance with GMP and regulatory requirements.
• Collaborate with cross-functional teams, including R&D, regulatory, technical operations, clinical supply, procurement, and external manufacturing partners.
• Provide quality guidance, training, and compliance advice to internal stakeholders and third-party organizations.
• Drive continuous improvement initiatives while managing multiple priorities and maintaining effective relationships with internal and external stakeholders.

Basic Qualifications:

• Bachelor's degree in Pharmacy, Science, Engineering, or a related discipline, or equivalent pharmaceutical GMP knowledge and experience.
• Minimum of 5 years of pharmaceutical manufacturing and/or quality assurance experience.
• Strong knowledge of cGMP, pharmaceutical regulations, quality systems, audits, CAPA, deviations, and GMP documentation.
• Experience working with contract manufacturing organizations (CMOs), suppliers, or other external pharmaceutical service providers.