Director, GLP Quality Assurance

Direct hire, full-time hybrid role located in Redwood City, CA.

About the Role

The Director, Good Laboratory Practice Quality Assurance (GLP QA) ensures GLP compliance at the company and for external vendors performing regulated work, including all GLP vendors.

Responsibilities

• Research laboratory vendors that perform work to support regulated clinical studies.
• Develop the annual vendor audit plan.
• Perform and/or manage vendor audits, including:
  • Development of the audit plan, audit conduct, and reporting.
  • Tracking and coordination of audit closure tasks, including review of observation responses from vendor(s) in conjunction with operational subject matter experts (SMEs).
  • Provision of vendor approval recommendations.
  • Maintenance of vendor approval status in Veeva.
• Develop and/or review Quality Agreements.
• Perform or participate in internal audits.
• Provide QA review of CRO study protocols and reports for compliance using a risk-based approach; serve as an advisor to Nonclinical Development and Clinical Pharmacology (NDCP) to resolve compliance issues.
• Monitor vendor QA units for compliance with applicable regulations, including review of vendor study-specific QA audit reports.
• Advise Sponsor(s) on compliance requirements for test and control articles used in GLP studies.
• Liaise and/or consult with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs, and other compliance issues.
• Provide annual GLP training or liaise with an external trainer to deliver GLP training to functional team(s).
• Attend functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or ongoing issues, projects, and/or studies.
• Work with QA management for resource planning as needed.
• Attend periodic clinical QA group meetings as needed.
• Provide periodic quality and compliance updates to QA management.
• Develop/prepare standard operating procedure (SOP) content for GLP audits and review functional area and QA SOPs for GLP compliance.
• Provide consultative QA guidance for computerized system vendors (and systems) supporting GLP studies.

Requirements

• Bachelor's or Master's Degree.
• 12+ years of experience in global Good Laboratory Practice (GLP) Quality Assurance (QA).
• Extensive audit and inspection management experience.

Preferred Qualifications

• Registered Quality Assurance Professional - Good Laboratory Practice (RQAP-GLP).
• Planning and scheduling expertise.
• Ability to effectively prioritize competing initiatives and tasks across multiple projects.
• Strong communication skills with senior leadership, management, and cross-functional teams.
• Ability to manage workstreams to maintain delivery timelines through disciplined planning, tracking, and follow-up.
• Ability to balance detail-oriented execution with strategic oversight.
• Experience with proactive identification, assessment, and mitigation of risks, and timely issue escalation.
• Regulatory expertise with the following:
  • 21 CFR Part 58 Good Laboratory Practice.
  • 21 CFR Part 11 Electronic Records; Electronic Signatures.
  • OECD #1 - 24 Standards and Advisory Documents on Good Laboratory Practices.
  • ICH E6 (R2 and R3) Good Clinical Practices.
  • Japanese Ministry of Health, Labor and Welfare (MHLW) - Good Laboratory Practice.
  • Applicable US and EU guidance documents, including bioanalytical, in vitro, and in vivo genetic, Phototox, and hERG toxicology studies.
• Experience with the following audit types:
  • Testing facilities.
  • Bioanalytical and PK data analysis Labs.
  • hERG and Phototoxicity testing facilities.
  • Archives - biorepositories, paper, and electronic data storage.
  • Computer Systems Validation.
  • Biomarker Labs (including Artificial Intelligence and Machine Learning).
  • Central Laboratories.

Skills

• GLP Quality Assurance.
• Global GLP compliance.
• 21 CFR Parts 11 and 58.
• OECD GLP, ICH GCP, MHLW GLP.
• Vendor qualification and oversight.
• Vendor and internal audits.
• Inspection management.
• Risk-based CRO oversight.
• Audit reporting and closure.
• CAPA and investigations.
• Quality Agreements.
• Veeva.
• SOP development.
• Regulatory compliance.
• Computerized systems validation.
• Laboratory and testing facility audits.
• Bioanalytical and PK audits.
• Toxicology studies.
• Biomarker and central laboratory audits.
• GLP training.
• Risk management.
• Resource planning.
• Project prioritization.
• Cross-functional leadership.
• Senior management communication.

Pay

$110 - $120 per hour.