Supplier Quality Manager - GMP
Newark Metro Area, NJ
- Supplier Quality Manager - GMP Pharma
This position provides quality oversight for contract or internal manufacturing organizations used to manufacture drug substance (API) and/or drug products in accordance with policies, standards, procedures and international cGMP s. The incumbent will oversee multiple products at various Contract Service Providers (CSPs).
- . REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Must have expert cGMP and Quality knowledge.
Must know how all stages of product development interrelate and how decisions or actions taken affect functional partners within and outside the Dev QA organization.
Must be able to critically interpret problems and effectively communicate in a productive manner to management, cross functional SMEs, and the broader organization with clarity and a high level of brevity and accuracy.
Must be able to recognize and group technical/scientific attributes in potential situations or issues and drive compliance based decisions across the function.
Must be able to critically interpret results and generate technical conclusions consistent with Quality risk principles.
Must be skilled in planning and organizing, conflict management, coaching others, decision-making, building relationships, and innovation management.
Thorough knowledge of and competence in core quality processes, including material disposition, change control, product complaints, deviations, root cause analysis, and CAPA management