Associate Director, Quality Assurance

The Associate Director (AD), Quality Assurance for UNITY Biotechnology assumes a leadership role in establishing, maintaining, and maturing compliant, efficient internal quality systems and procedures related to the manufacture, packaging, testing, and disposition of drug substances and drug products at CMO’s. Quality systems include, but are not limited to: Investigations/CAPAs Change Control, Quality Metrics, Management Review, Investigational Product Complaints, Training, Audits, and Supplier Management.

Roles and Responsibilities

  • Independently manages review and approval of master batch records, labels, specifications, and other manufacturing documents of clinical drug substances and drug products in compliance with all applicable requirements.
  • Independently manages review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigational reports related to production and disposition.
  • Leads weekly QA to QA meetings and represents QA in weekly meetings with CMOs.
  • Leads the initiation, review, and approval of change control requests to ensure compliance with all applicable requirements.
  • Lead Quality representative, including compliance responsibility, on the internal project teams.
  • Leads and trains others (as appropriate) in audit and vendor management programs.
  • Prepares and presents quality metrics.
  • Independently initiates and approves SOP updates and creation of new SOPs.
  • Lead establishment and implementation of Quality-specific documents (e.g. Quality Risk Management Plan, Quality Agreements)
  • Ensure Quality processes across the clinical supply chain comply with all applicable regulations and guidelines.
  • Other responsibilities as needed and assigned by supervisor.

Qualifications

  • Minimum BA/BS degree preferably in a scientific discipline.
  • Extensive experience with manufacturing of small molecules (regulatory starting material, API), and aseptic drug product manufacturing
  • Excellent working knowledge of global GMP regulations, ICH guidelines, and robust Quality Systems.
  • Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background.

Education and Experience

  • 4

Working Conditions

  • Office Based Position. Travel Requirement 10-30%.