Associate Director, R&D Quality Assurance

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