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Director of Quality Assurance

1 month ago

Fishers, United States INCOG BioPharma Services Full time

Essential Job Functions:

  • Execute and maintain Quality Assurance oversight of manufacturing, packaging, and quality control testing activities.
  • Ensure that key QA functions (batch release, material release, data review, validation oversight, manufacturing QA) are performed and documented in compliance with global health authority regulations and expectations, as well as INCOG procedures.
  • Provide review and/or approval of master batch records, deviations, and CAPAs related to areas of oversight.
  • Maintain responsibility for QA metrics development, management, and reporting.
  • Participate in material planning and Ready to Execute meetings to ensure QA items are ready, as well as partner with other departments (MSAT, Supply Chain, QC, Validation) to ensure their deliverables meet global health authority regulations and expectations, as well as INCOG procedures.
  • Participate in business development meetings/discussions with INCOG clients representing QA and INCOG’s quality systems.
  • Participate in client and regulatory audits as required.
  • Participate in routine client meetings to represent QA and INCOG’s quality systems.
  • Act as the delegate for the VP of Quality as needed.
  • Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QA and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.


Special Job Requirements:

  • Bachelor’s degree in science.
  • Minimum of 15 years of biopharma industry experience, of which at least 5 years have been in a role of hands-on experience with Quality Assurance in aseptic manufacturing facilities.
  • Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for aseptic manufacturing facilities.
  • Experience with leading initiatives to drive a culture of delivery and compliance within a regulated manufacturing environment.
  • Possess skills in leadership, communication, project management, and budget management, while maintaining extremely high quality and efficiency standards.
  • First-hand experience participating in and/or hosting audits/inspections.
  • Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.).


Additional Preferences:

  • Experience with high-growth companies.
  • Experience with packaging and labeling operations, inclusive of serialization.
  • Experience with combination products regulations.
  • Previous supervisory experience.
  • Previous experiencing mentoring and developing people leaders