Product Manager
Core
Coordinate overall operations of the Quality Assurance function for assigned pharmaceutical products and customers, serving as the central contact for quality inquiries to ensure patient safety and compliance.
Role type
Quality Assurance Product Manager
Builds
Safe and compliant pharmaceutical products for patients
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
Quality system management, regulatory compliance (GMP, FDA, USP), audit coordination, statistical analysis, investigation management, Quality Agreement drafting, client partnership management, documentation, Microsoft Office proficiency
Preferred skills
Manufacturing environment auditing, training others, Trackwise and JDE experience
Responsibilities
Act as primary quality liaison for clients and internal customers; support new and commercial products and processes; assist with internal, client, and regulatory audits; maintain systems and procedures to monitor quality system health; perform statistical analyses and provide routine metrics; represent Quality in business update meetings; coordinate internal QA functions including reviewing investigations, handling complaints, trending data, and approving qualification reports; maintain client data sets; interface with Operations and Customer Service for third-party manufacturing compliance.
Seniority
Mid-level, hands-on IC
