Director of Quality Assurance

3 weeks ago


New York, New York, United States Sterling Life Sciences Full time

Director of Quality Assurance

Sterling Life Sciences is seeking a highly skilled Director of Quality Assurance to lead their quality management team. The ideal candidate will have a strong background in quality management and a proven track record of ensuring process reliability and compliance with regulatory requirements.

Key Responsibilities:

  • Provide technical quality support for internal and external teams and projects
  • Ensure robustness of process to meet CPPs and CQAs
  • Oversee analytical methods validation and process validation for insulin analog drug substance and product
  • Review and approve procedures, master batch records, and other documentation
  • Review and approve quality system records, including change requests, deviations, and CAPA
  • Provide quality input to new facility design changes
  • Decision-maker for validation/qualification of insulin biosimilars and escalation of issues to management
  • Oversee disposition of drug substance
  • Ensure manufacturing and QC adherence to company policies and procedures, regulatory licenses, industry standards, and GMP regulations
  • Represent QA during site health authority inspections and business forums
  • Ensure staff training and development
  • Partner with and influence other departments and functions to implement ongoing product and process robustness

Critical Requirements:

  • A university degree is required
  • Appropriate full-time work experience is mandatory
  • Recent experience in the pharmaceutical industry is strongly preferred
  • Preference will be given to candidates with recent experience in quality management

This is a highly competitive opportunity for a seasoned quality professional to join a well-established company in the pharmaceutical industry.



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