Oral Site Quality Lead
Core
Lead the site Quality team to ensure effective implementation of GMP, quality standards, and SOPs; manage batch release, validation, supplier qualification, and regulatory compliance for a pharmaceutical manufacturing facility.
Role type
Senior Site Quality Lead (Pharmaceutical Manufacturing)
Builds
Pharmaceutical products (OTC and prescription) compliant with global registration requirements and quality standards.
Domain
Pharmaceutical manufacturing / Life Sciences
Required skills
GMP compliance, Quality Management System (QMS) design and maintenance, batch release decision-making, validation and qualification, supplier qualification and monitoring, regulatory compliance, CAPA management, risk management, budget ownership, team leadership and development.
Preferred skills
None stated.
Technologies
None stated.
Responsibilities
Lead the site Quality team and provide direction on quality and compliance matters; Ensure effective implementation of applicable GMP, Company Quality Standards, SOPs and relevant policies; Review and approve all quality-related changes; Ensure compliant review of batch records and test results prior to product release; Oversee maintenance of premises, facilities and equipment; Assess and approve material suppliers; Work with Regulatory Affairs to oversee site product registrations; Effectively manage internal and external audit and inspection programs; Lead and drive the site compliance training system.
Seniority
Senior, hands-on IC
