Director/Senior Director, Quality Control

5 days ago

Minnesota, United States Alternative Resources Company Full time

Director/Senior Director, Quality Control

The Director/Senior Director will be responsible for leading the Quality Control Laboratory and oversight of Contract Testing QC labs in support of clinical manufacturing, establishment of internal QC processes, and maintenance of the control strategy for investigational products and moving towards licensure.

Responsibilities

  • Plan and able to perform multiple bioanalytical assays
  • Manage QC quality records including, but not limited to, Out-of-Specification Investigations, Deviations, CAPAs, and Change Controls, and ensure all related activities are completed in a timely manner
  • Establish routine operations to govern QC activities, including scheduling sample testing, performing documentation reviews, ordering supplies, and oversight of QC equipment maintenance and calibration
  • Serve as the QC Subject Matter Expert (SME)
  • Author, review, and approve QC-related documentation (CoA, Methods, SOPs, reports, etc.) and provide documentation support to QA, as needed
  • Collaborate with the Research and Product Development team in the transfer of analytical assays to QC
  • Coordinate with Manufacturing for in-process and product release test sample submission and testing
  • Direct testing for and support the product stability program
  • Attend functional and cross-functional meetings to discuss ongoing work and align priorities
  • Lead the efforts for the Quality Control Laboratory to obtain an FDA Establishment Identifier number
  • Manage, coach, and develop the growing team of QC Scientists

Qualifications

  • BS or MS degree in Biology, Biochemistry, Chemistry, or a relevant scientific discipline is required, at a minimum
  • 8-10+ years of relevant biotech/pharma industry experience, including Quality Control experience supporting cGMP areas
  • 3+ years' experience supervising/managing direct reports
  • Experience in western blot, flow cytometry, cell-based assays, particle size analysis, Karl Fischer assay, compendial assays
  • Demonstrated industry knowledge of cGMP
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes
  • Strong communications skills: a team player who can lead, mentor, and inspire others
  • Experience participating and/or supporting regulatory inspections preferred
  • Biologics experience required, cell therapy product experience preferred

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