Senior Manager / Associate Director, QA

Harpoon Therapeutics is a clinical-stage immuno-oncology company focused on the discovery and development of novel, proprietary bispecific T cell engaging biologic drug candidates for the treatment of various cancers. Harpoon’s first product, HPN424, is in clinical development for prostate cancer, and the second product HPN536 is in clinical testing for mesothelin over-expressing tumors, such as lung, pancreatic and ovarian cancers . Harpoon currently has two additional products in development and intends to introduce these into clinical development by the end of 2020. Harpoon is led by an experienced management team and has raised more than $200 million from leading life science investors. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and clinical research.

We are seeking a highly motivated individual to be the Sr. Manager/Associate Director of QA. This individual will report into the Sr. Director, QA and play an essential role in maintaining, supporting reliable and quality supply of Harpoon products to clinical sites. The role will also involve implementing, scaling and maintaining a phase appropriate quality system while working closely with internal stake holders (e.g. CMC and Clinical).  

Key Responsibilities

  • Primary responsibilities entail working with internal and external stake holders (CMOs) to meet Harpoon’s timelines for finished drug product release (IND enabling and routine supply)
  • In conjunction with CMC and product development, oversee review and approval of product specification documents
  • If necessary, author and or negotiate terms of quality agreements with CMOs in conjunction with the Senior Director of Quality
  • Work with Qualified professionals (QP) to enable completion of batch record review in support of QP certification for distribution of Harpoon products in EU (Annex 16) to the clinic
  • Support QA oversight of stability protocol data review and expiry dating of Harpoon products
  • Work with CMOs to perform investigations in support of product quality (as applicable)
  • Implement and maintain key elements of ICHQ10 Quality System at Harpoon (Change control, deviations/CAPA, product complaints etc.)
  • Participate in CMO/GMP compliance audits (as required)
  • Any supplemental experience in clinical QA is a plus, but not a core requirement

Skills and Qualifications

  • BS/MS in Science or Engineering with at least 5 to 7 years in a Quality Operations, Quality Management or manufacturing role, in a late stage or early stage start-up biotechnology/pharmaceutical company (Prior experience as a Manager or Senior Manager a plus).
  • Prior experience overseeing CMO quality for batch record review, deviation investigation resolution for biologic drug substance and finished drug product. This could be a combination of working in Quality Operation/Manufacturing roles (primarily in downstream purification)
  • Experience in aseptic validation and aseptic processing a plus (e.g. media fill program evaluation). Lyophilized products is a plus 
  • Some level of experience in auditing CMO sites for GMP compliance, Quality Systems and assessing process capability
  • Working level knowledge in key quality systems such as change control, deviation/discrepancy management and product complaints
  • Experience with implementing 21 CFR part 11 compliant document management and Quality Management System is a plus (e.g. Veeva or track wise)
  • Additional skills, any experience or knowledge in Clinical Quality Assurance is a plus (auditing CROs, trial master files etc.)
  • Appreciation of quality risk management concepts
  • Demonstrated confidence in decision making
  • Proficiency in ICH10 requirements
  • Working knowledge of 21CFR US FDA regulations, ICH guidance and Eudralex GMPs
  • Strong negotiation and influencing skills with internal and external stake holders
  • Excellent verbal and written communication, strong organizational and interpersonal skills
  • Ability to work both independently and collaboratively in a fast-paced matrixed environment