Senior Director, Quality Assurance
Harpoon Therapeutics is a clinical-stage immunotherapy company located in South San Francisco. Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
Harpoon is seeking a Head of Quality Assurance (QA) to join our team to lead a Quality Assurance department that combines external QA consultants with an in-house model to support Harpoon’s development pipeline. This hands-on leadership position will be responsible for GxP Quality activities across the Harpoon portfolio of early development programs. H/She will work with Harpoon executive management to provide proactive strategic guidance, set policy, and address compliance issues.
- Implement process improvements as needed to ensure GxP compliance in an early clinical development environment with a strategic view to grow the Quality function as the products advance to late-stage development and potential commercialization
- Ensure the adequacy of the Quality Management System (QMS) components, including creation and revision of SOPs and training programs for GxP compliance, and documentation of QMS-required training
- Represent Quality Assurance on cross-functional teams, as appropriate, and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices
- Work with internal R&D functions and external parties including development partners, consultants, contract auditors, CDMOs, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs.
- Oversee or lead inspection activities (preparation, conduct, and response) for regulatory inspections internally, and at investigator sites, when appropriate; facilitate internal reviews of processes; assist in preparation of responses to findings; ensure completion of commitments
- Identify and address risk and implement preventative measures; assist in the development of corrective and preventive action plans following identification of compliance issues/concerns with both internal and external personnel (e.g., investigator sites and vendors); monitor
- progress on successful completion; review / approve deviations and QA-Controlled procedures
- Participate in outsourcing vendor evaluation and selection, conduct vendor audits, as appropriate; ensure robust vendor oversight, and establish Quality Agreements
- Provide expertise and guidance on GxP and applicable regulations to development teams to proactively identify compliance issues/risks and recommend mitigation
- Lead investigations into significant quality issues, suspected scientific misconduct and suspected serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate
- Manage audit program for investigational sites, utilizing findings to improve procedures and/or coach clinical teams
- In collaboration with subject matter expert, provide quality oversight related to GMP activities including oversight and approval of Method Validation, Release testing, and Stability for Drug Substance and Drug Product
- Work cross-functionally with CMC and CDMOs to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
- Review and approval of CMO master documentation (e.g., specification documents, master batch records, label proofs, etc.) as well as perform review of executed batch records, applicable test data (in-process and release) and performing product dispositions.
- Work with Qualified Persons (QP) to support QP certification for distribution in EU/UK
- Maintain awareness and inform upper management of potential issues impacting Harpoon’s business processes
- A BA/BS, MA/MS or PhD in a scientific discipline or related field
- Greater than 8 years’ experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industry
- Ability to translate strategy into action with minimal supervision; and the ability to impact and influence with strong negotiation and presentation skills
- In-depth knowledge and experience implementing phase-appropriate QMSs to achieve and maintain GxP compliance
- Strong understanding and interpretation of GCP, GLP, GMP and best quality practices relative to biotech and pharmaceutical products
- Experience with and responding to regulatory agencies (e.g., FDA, EMA, MHRA, and BfArM) preferred
- Excellent interpersonal and written and oral communication skills, ability to develop important relationships with customers and key stakeholders, good conflict resolution skills
- Demonstrated ability to be results and detail-oriented; self-motivated