Associate Director/Director, Quality Systems
Harpoon Therapeutics (ticker: HARP) 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. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. 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 cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. 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.
We are seeking a highly motivated individual to serve as the Associate Director or Director of Quality Systems at Harpoon. This individual will report into the Vice President, Regulatory Affairs and Quality Assurance, and will play an essential role in developing and maintaining quality systems that support and ensure GxP compliance, including the document management system, training systems, GxP vendor management, change control, CAPA systems, and metrics reporting for Quality Management Review.
The AD/Director, Quality Systems will work closely with members of the Quality Operations, Product Development, and Development Operations teams to assure that Quality Systems are implemented in a phase appropriate manner meeting Regulatory and Quality requirements.
- Develop a long term compliance strategy for Quality System design and growth
- Develop and maintain a GxP compliant document control function with appropriate processes, procedures, and practices; maintain the Electronic Document Management systems.
- Implement and manage the GxP training curriculum, system and records.
- Manage the change control, deviation, and CAPA quality systems
- Implement and manage a GxP audit plan (internal processes and external vendors), track observations, and coordinate responses with appropriate department managers.
- Manage and provide QA expertise for validation of GxP computerized systems, including new system implementations and ongoing system updates.
- Prepare for and manage Quality Management Reviews.
- Develop and report monthly QA metrics to monitor compliance.
- Provide QA expertise, advice, or assistance to other departments as required.
- Manage direct reports as necessary to support the Quality Systems function.
- Work with QA Operations and CMOs to perform investigations in support of product quality.
- Participate in CMO/GMP compliance audits as required.
Skills and Qualifications
- BS/MS in Science or Engineering with at least 10 years in a Quality System or Quality Management in a biotechnology/pharmaceutical company.
- Prior experience overseeing CMOs, including deviation investigations, CAPA implementation and effectiveness checks, auditing CMO sites for GMP compliance, Quality Systems and assessing process capability.
- Experience implementing and managing key quality systems such as change control and deviation/discrepancy management.
- Experience with a 21 CFR part 11 compliant document management system (e.g. Veeva or similar systems).
- Experience with validated computer systems including system updates and maintenance.
- Additional skills, 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.
- Working knowledge of US FDA and EU regulatory requirements for biologics or pharmaceuticals including US FDA CFR Parts 210 and 211, ICH Q7 and Q10, EU Directive 2001/20/EC.
- 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.