Associate Director of Global Quality

Overview

Antheia is a next‑generation biosynthesis company that produces high‑value pharmaceutical ingredients faster and with less supply chain risk than legacy approaches. The company delivers a resilient, efficient supply to global pharmaceutical customers while expanding the innovation frontier for new therapeutic development.

• Serve as the primary quality representative for Antheia’s direct manufacturing operations for regulated starting material (RSM) and pharmaceutical active pharmaceutical ingredient (API), ensuring compliance with GMP regulations (21 CFR Parts 210/211, ICH Q7, and relevant EU GMP guidelines).
• Create processes for and execute the review, approval, and release of batch production and control records; oversee in‑process testing and finished‑product disposition decisions.
• Own and maintain the site quality management system (QMS) for manufacturing operations, including change control, document control, training programs, and internal audit schedules.
• Partner with Manufacturing, Process Development, and Engineering teams to embed quality by design (QbD) principles from development through commercial production.
• Provide periodic on‑the‑floor presence during critical manufacturing campaigns, serving as a visible quality authority and mentor to site quality staff.
• Lead site readiness activities for regulatory agency inspections (FDA, EMA, DEA, and other competent authorities); serve as Quality host during inspections of Antheia’s facilities.
• Drive risk management activities in accordance with ICH Q9, identifying and mitigating quality risks across the supply chain.
• Build and maintain an effective supplier quality program in partnership with Supply Chain, qualifying key RSM and excipient suppliers and overseeing supplier audit programs.

• 10–15+ years of progressive quality experience in a regulated pharmaceutical or life sciences environment, with significant experience in API and/or RSM manufacturing quality.
• BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
• Deep working knowledge of ICH Q7 (GMP for APIs), ICH Q10, ICH Q9, 21 CFR Parts 210/211, and EU GMP Annex requirements applicable to API and starting material manufacture.
• Experience supporting regulatory agency inspections (FDA, EMA, or equivalent) and responding to agency observations.
• Strong working knowledge of change control, document control, validation, and qualification systems in a pharmaceutical manufacturing context.
• Well‑organized, detail‑oriented, and analytically strong; able to manage multiple concurrent priorities in a dynamic, growth‑stage environment.
• Excellent verbal and written communication skills; able to present complex quality topics clearly at all organizational levels.
• Willingness to travel domestically and internationally (estimated 25+%) to support site and CMO activities.

• Experience with controlled substance API manufacturing and familiarity with US DEA regulatory requirements (registration, recordkeeping, reporting, and quota management).
• Prior experience in a biotechnology, synthetic biology, or fermentation‑based manufacturing environment.
• Exposure to regulated starting material (RSM) designation under ICH Q11 and the associated regulatory strategy considerations.
• Experience with international CMO networks spanning North America and Europe.
• Familiarity with Drug Master File (DMF) or Active Substance Master File (ASMF) dossier compilation and maintenance.
• Experience with QMS, ERP, MES, and CCMS platforms (e.g., Veeva, SAP, Track Wise, Master Control or equivalent).
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.

• Full‑time base salary range of $156,000 – $220,000 plus an annual bonus potential and equity opportunities. Compensation will be adjusted based on applicant's location.
• Remote hybrid role available; preference for proximity to Menlo Park, CA headquarters.
• Annual bonus potential and equity opportunities.
• Paid time off, company‑observed holidays, and 401(k) retirement savings plan.
• Excellent medical, dental, and vision insurance.
• Free access to the Menlo Park Labs Gym and free shuttle service to Cal Train, BART station, and San Francisco.

Antheia is an equal opportunity employer and does not discriminate based on age, race, ethnicity, national origin, religion, gender, sexual orientation, disability, medical history, and other non‑merit characteristics.