Manager, Clinical QA

Location
94080, South San Francisco
Posted
Jul 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

Description:

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. 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 small cell lung cancer and other DLL3-associated tumors. 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. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.

The Manager of Clinical Quality Assurance is responsible for partnering with Development Operations, Clinical Science, Regulatory Affairs, and Translational Medicine to ensure Quality and Compliance across all the GCP systems and activities, drive continuous improvement, and serve as an active member of the Quality Team. This role is instrumental in integrating and monitoring quality throughout all steps of the clinical product development process; auditing studies and Trial Master Files for GCP compliance; and using risk assessments and tracking and trending the key metrics to drive improved compliance and quality of the GCP activities. The Manager of Clinical Quality Assurance will manage an audit schedule and may participate in audits. This position reports to the Vice President of Regulatory Affairs and Quality Assurance and is a member of the Quality Team, driving functional and cross-functional projects that embed continuous improvement principles across the company.

Specific responsibilities include:

  • Establishing and maintaining the GCP QA programs, policies, and procedures; ensuring cGCP compliance of clinical trials
  • Partnering with internal Development organizations including Clinical Operations, Clinical Sciences, Translational Medicine, Regulatory Affairs, and Clinical Supply Chain Management to support compliance of Harpoon’s clinical trials
  • Acting as a Clinical QA contact for Clinical vendors, contract facilities, and contract service providers
  • Ensuring compliance with applicable health authority regulations and guidelines for document management and software used in GCP processes
  • Writing and maintaining Clinical QA SOPs; reviewing other functions’ SOPs for GCP compliance
  • Understanding and interpreting regulatory policies and guidance as they pertain to GCP requirements
  • Participating in the QA review of clinical trial documentation and documents submitted to regulatory authorities including Informed Consent Forms, Investigator’s Brochures, Clinical Study Protocols and Reports
  • Participating in the QA review of nonclinical study reports and other documentation
  • Ensuring compliance of Trial Master Files housed by Harpoon and CROs
  • Contributing to Sponsor and/or Clinical Trial Site inspection readiness related to GCP
  • Participating in audits (on site and remote) of Clinical Trial Sites, Clinical Trial Master Files, and Contract Research Organizations to ensure the compliant conduct of Harpoon-sponsored clinical trials
  • Monitoring current and projected quality issues and advising management on risk.

Requirements:

Minimum Education/Experience

  • Bachelor’s degree (or equivalent) in life sciences
  • 5+ years of experience in the pharmaceutical industry, or equivalent, in Clinical Quality Assurance
  • Current GCP training certificate
  • Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, the regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD and other global standards

Qualifications:

Other Qualifications

  • Qualification as an auditor advantageous (eg, RQAP-GCP, ASQ CQA)
  • Experience with GLP compliance advantageous
  • Able to function independently as well as part of a team
  • Ability to coordinate the efforts of team members to resolve comments and questions
  • Independently motivated with good problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines
  • Strong oral, written, and interpersonal skills and attention to detail
  • Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
  • Experience with EDMS such as Veeva Vault advantageous
    • Travel may be required