Summary
Our client, a first-in-class biopharmaceutical client located in Southern California, is seeking an Associate Director, R&D Quality Assurance (Early-Stage Development) to support their expanding pipeline. This individual will lead quality assurance activities for early-phase clinical development, working cross-functionally to ensure compliance, manage vendor relationships, and mitigate risk across development programs. This role operates in a fast-paced, high-performing environment and requires strong collaboration, technical expertise, and the ability to operate under pressure as an individual contributor.
Duties / Expectations of Role
Quality Assurance Leadership
- Lead and oversee QA activities for early-stage (preclinical through Phase I/II) development programs
- Develop, implement, and maintain Quality Management Systems (QMS) supporting early development
- Ensure compliance with global GxP regulations (GCP, GLP, GMP) and internal standards
- Serve as QA representative on cross-functional project teams
Cross-Functional Collaboration
- Provide QA guidance to Clinical, Regulatory, Analytical Development, Supply Chain, and CMC teams
- Advise on risk mitigation strategies across programs
- Participate in internal and external operational and vendor meetings
Vendor & External Partner Management
- Oversee contract manufacturers (CMOs), testing labs, packagers, raw material suppliers, and warehouses
- Support vendor qualification, audits, and quality agreements
- Troubleshoot manufacturing issues and collaborate with vendors on resolution
Quality Systems & Documentation
- Review and approve:
- Investigations (deviations, OOS, production issues)
- Change controls (MMRs, test methods)
- Validation protocols and reports
- Batch records (master and executed) and product disposition
- Contribute to SOPs, protocols, reports, and regulatory submissions
Operational Responsibilities
- Participate in blinded clinical study support (2–3 arms)
- Manage and approve batch release for clinical trial materials
- Support analytical documentation and validation processes
Candidate Profile & Fit
Must-Have Qualifications
- 12+ years of experience (or 7+ years with advanced degree) in Pharma QA
- Strong experience across early development (formulation → Phase I → Phase II)
- Experience with sterile manufacturing (e.g., ointments, sterile products)
- Experience working with CMOs, testing labs, and cross-functional teams
- Strong knowledge of quality requirements across development phases
- Experience troubleshooting and resolving vendor/manufacturing issues
- Bachelor’s degree in a scientific discipline
- Ability to work under pressure and extended hours when needed
- Comfortable operating as an individual contributor initially
- Stable background with strong track record in reputable organizations
Nice-to-Have Qualifications
- Experience taking products through commercialization
- Master’s degree
- Tablet manufacturing experience
- Experience supporting regulatory submission writing
Term & Start
- Full-time, permanent role
- Hybrid: 3 days onsite (Irvine, CA)
- Preference for candidates in San Diego or West Coast time zone
- Travel: ~15% (including quarterly onsite “anchor week”)
- Start: ASAP
- Full client benefits, bonus, and stock options
