Senior Director, Quality Assurance
South San Francisco, CA
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
Harpoon anticipates that the annual base salary for this position could range from between $230,000 to $260,000 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Harpoon is a multistate employer and the salary offered will be market competitive. At Harpoon, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.