Senior Manager, Product Development Quality Assurance (CMC Product Lead)

Responsibilities

• Provide program oversight for the RDQA QA organization; includes timely communications on program strategies and issue management.
• QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
• Lead complex global cross-functional process improvement teams.
• Provide innovative and risk-based solutions to complex technical problems.
• Support the preparation of regulatory inspections and internal audits, and represent Quality in inspections and audits.
• Write/ review/ approve exception reports, including high impact and complex ERs impacting multi-functional areas.
• Provide management of clinical supply product actions and recalls.
• Support in-licensing and collaboration activities.
• Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers and other sites.
• Interact and influence decisions of the various R&D Directors and VP as well as external customers and mentor staff.

  Qualifications

  • Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
  • Masters degree is preferred but is not required based on commensurate experience.
  • 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
  • Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is required. Experience applicable to investigational products is preferred.
  • Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
  • Strong leadership, communication, and organizational skills.
  • Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.