Associate Director/Director, Quality Assurance

94080, South San Francisco
Sep 21, 2018
Assoc. Dir./Dir., QA
Required Education
Bachelors Degree
Position Type
Full time

Harpoon Therapeutics is an early-stage biotech company located in South San Francisco. The Company is developing biologics with novel molecular formats to engage and activate immune cells for the treatment of cancer and other diseases. With one program in the clinic and multiple programs positioned to enter clinical development in the next two years, we are becoming a clinical stage company. We are seeking a highly motivated Assoc. Director/Director of Quality Assurance to execute strategic and operational QA activities. This individual will report into the CEO and play an essential role in providing QA oversight, management review, and organization of complex and intertwined CMC – related and clinical activities at preselected contract research and manufacturing organizations.     

Harpoon has implemented a Quality System which provides the necessary basis to work with external cGMP-compliant contract manufacturers (CMOs) and other cGMP service providers during the development of Harpoon’s products in a phase-appropriate manner and fulfills Harpoon’s responsibilities in context with the final release of our products for clinical use. Harpoon has initiated implementation of Quality support for clinical trials as well.         

Key Responsibilities

  • Maintenance and updating/expansion of Harpoon’s Quality System and administration of the QA functions including overall QA document management and organization
  • Coordination of review and approval of cGMP documents including batch records (master and executed), quality standards, release and stability protocols, and other relevant documentation
  • Harpoon disposition of Drug Substance batches and Drug Product lots for clinical use
  • Preparation of a Quality Target Product Profile (QTPP) for each new product
  • Documentation of Critical Quality Attributes (CQA) assessment of each product
  • Prepare internal specifications for Drug Substance and Drug Product in collaboration with SVP Product Development and external vendors
  • Negotiate Quality Agreements with CMOs and other cGMP service providers
  • Perform cGMP Audits of CMOs and other service providers
  • Oversee and support clinical and regulatory QA functions to ensure completeness and consistency

Skills and Qualifications

  • B.S., M.S., or Ph.D. Degree in biology, biochemistry, chemical engineering, or related field 
  • Minimum 7-10 years industry experience in pharmaceutical or biopharmaceutical quality assurance
  • Experience providing quality oversight when working with external vendors (Contract Manufacturing Organizations) essential
  • Experience with review and approval of cGMP documentation including batch records, quality standards, release and stability protocols, and release documentation
  • Excellent verbal and written communication, strong organizational and interpersonal skills
  • Ability to work in a dynamic, fast-paced, timeline-based environment