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.
At ARS, we are proud to offer a highly competitive compensation & benefits package.
The full-time salary range for this posted position is
$206,000 to $230,000 and may be eligible for a discretionary annual performance bonus. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.
This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: ARS Careers Page
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
