JOB SUMMARY:

This role is a senior individual contributor role that will work an onsite hybrid schedule at our San Diego corporate office in the Carmel Valley are.  The Associate Director / Director, Quality Assurance owns the systems that keep us inspection-ready: document control, GMP training, and the vendor and supplier qualification and audit program. You will build and scale the Quality Management System for an outsourced manufacturing model, lead cross-functional quality initiatives, and act as a senior quality voice with contract manufacturers, suppliers, and regulators.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Quality leadership

• Serve as a senior QA leader, partnering with the Head of QA to set quality strategy, priorities, and annual objectives.
• Lead cross-functional quality initiatives with Manufacturing/CMC, Regulatory, Supply Chain, Clinical, and Commercial teams.
• Own QA metrics and KPIs; prepare inputs for quarterly Management Review.
• Lead inspection readiness and act as a front-room host or SME during FDA and other regulatory inspections.
• Coach and mentor QA and cross-functional colleagues on GMP expectations; deputize for the Head of QA when needed.

Document management

• Own the document control system (e.g., Veeva Vault QualityDocs): SOPs, work instructions, forms, specifications, and controlled records.
• Manage the document lifecycle: authoring templates, review and approval routing, periodic review, effective dates, and archival.
• Ensure Part 11 and data integrity (ALCOA+) compliance for electronic records and signatures.
• Maintain record retention schedules and inspection-ready retrieval.

Training

• Own the GMP training program: role-based curricula, training matrices, and new-hire onboarding.
• Deliver or oversee annual cGMP, data integrity, and SOP training.
• Track completion and training effectiveness; escalate overdue training and close gaps found in audits.

Vendor and supplier audits

• Own the supplier qualification program: risk-based classification, approved supplier list, and requalification schedule.
• Plan and run the annual audit schedule for CMOs, testing labs, API and excipient suppliers, component and device suppliers, and GxP service providers.
• Lead on-site and remote audits; write reports, approve audit responses, and verify CAPA effectiveness.
• Negotiate and maintain quality agreements; monitor supplier performance and escalate quality issues.
• Support internal audits of QMS processes

KNOWLEDGE, SKILLS, AND ABILITIES:

• Influence: gets alignment from peers, partners, and executives without line authority.
• Systems thinking: designs quality processes that scale and stay inspection-ready.
• Audit judgment: finds real risk quickly and grades findings in proportion to it.
• Communication: writes clear audit reports and presents confidently to regulators and leadership.
• Office-based in San Diego (preferred), with domestic and international travel up to 25% for audits, including time in GMP manufacturing areas with gowning.

 EDUCATION AND EXPERIENCE:

Required

• Bachelor's degree in a scientific or engineering discipline; advanced degree a plus. An acceptable combination of education and relevant experience will also be considered
• Minimum of 10+ years of QA experience
• Progressive QA experience in pharmaceutical, biotech, or combination products, including commercial-stage products.
• Hands-on ownership of document control and GMP training systems.
• Lead auditor experience with CMOs and suppliers; strong knowledge of 21 CFR 210/211, Part 11, ICH Q7–Q10, and EU GMP.
• Proven ability to lead cross-functional work and influence without direct authority.
• Direct participation in FDA or EU regulatory inspections.

Preferred

• Drug-device combination product experience (21 CFR Part 4, 820 / QMSR, ISO 13485).
• Veeva Vault QMS/QualityDocs administration or implementation.
• ASQ CQA or other lead auditor certification.
• Experience building quality systems at a small, virtual, or growing company.