Associate Director, Process Development Documentation QA

The Associate Director of Process Development and Documentation in Quality Assurance is a key member of the CQA team at our innovative Biotech client in the San Francisco Bay Area. This person will lead day-to-day clinical quality operations and compliance activities related to the development and documentation of processes that support successful execution of clinical studies.

Responsibilities:

• Lead process development and documentation activities in collaboration with Clinical Development functional teams to support clinical study success

• Manage and/or lead cross-functional teams to develop SOPs aligned with GCP, GVP, and GLP requirements

• Partner with functional teams to guide process development, SOP writing, and ensure timely SOP reviews and updates

• Serve as a subject matter expert for SOPs and provide process compliance guidance to clinical study teams

• Participate in the review and approval of clinical study documents and SOPs/Guidance Documents as needed

• Develop and manage SOP timelines to ensure adherence to review cycles and regulatory-driven updates using a risk-based approach

• Drive continuous improvement initiatives for the Clinical Quality Management System (CQMS), including SOP and training program development to support GCP, GLP, and GVP compliance

• Lead or support inspection readiness efforts across the development organization

• Provide support for regulatory inspections, including sponsor audits, clinical investigator site inspections, CRO inspections, and others such as GMP, GLP, or PV inspections as needed

• Contribute to qualification audits of service providers, investigator sites, and internal clinical functions, including study documentation reviews such as TMFs and CSRs, with emphasis on SOP compliance

• Investigate clinical non-compliance events, implement CAPAs, and conduct trend analysis and effectiveness checks

• Support team growth and capability development by mentoring junior QA staff and contributing to a positive and high-performing team culture

• Analyze and report quality metrics related to clinical study deviations, CAPAs, and other study data including protocol deviations and safety-related findings

• Stay up to date on regulatory and industry trends related to clinical quality processes and SOP best practices; assess impact and implement changes to maintain compliance

• Provide cross-training and mentorship opportunities across the QA function

• Minimal travel required

Preferred Skills, Qualifications, and Technical Proficiencies:

• Strong technical writing skills

• Experience in process development, mapping, and documentation

• Proven expertise in GCP, GLP, and GVP process development and training on SOPs and applicable regulations

• Experience supporting regulatory agency inspections

• Solid understanding of quality systems supporting GCP, GLP, and GVP for both clinical documentation and commercial activities

• Proficient in Microsoft Office (Word, Excel, PowerPoint)