Associate Director of Global Quality

Job Description

Antheia is seeking an experienced and driven Associate Director of Global Quality to provide hands-on quality leadership across our regulated starting material (RSM) and pharmaceutical active pharmaceutical ingredient (API) operations. This role carries accountability for both direct manufacturing oversight at Antheia-operated sites and contract manufacturing organization (CMO) oversight, ensuring all products meet applicable quality and regulatory requirements and the highest standards of quality.

The successful candidate will be a decisive quality professional with deep expertise in ICH guidelines, GMP regulations, and the unique compliance demands of regulated starting materials and pharmaceutical API manufacture. This individual must be equally comfortable conducting in-depth technical review of batch records and deviation investigations as they are engaging with multiple external partners, regulatory agencies, and cross-functional leadership.

Reporting to the SVP of Quality Assurance & Regulatory Affairs, the Associate Director of Global Quality is a critical member of the Quality leadership team. This role may be hybrid or remote, with preference for proximity to Menlo Park, CA, and will require periodic domestic and international travel to manufacturing sites and CMO partner facilities.

Responsibilities

Direct Manufacturing Quality Oversight

• Serve as the primary Quality representative for Antheia's direct manufacturing operations for RSM and pharmaceutical API, ensuring compliance with applicable GMP regulations (21 CFR Parts 210/211, ICH Q7, and relevant EU GMP guidelines).
• Create processes for and then execute the review, approval, and release of batch production and control records; oversight for in-process testing and finished-product disposition decisions.
• Oversight for deviation investigations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for internal manufacturing, ensuring timely closure and robust root cause identification. Tracking and trending of critical quality attributes for reporting purposes.
• 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 the site quality staff.

Contract Manufacturing Organization (CMO) Oversight

• Serve as the lead Quality representative for all CMO relationships, establishing robust quality agreements and technical agreements aligned with regulatory requirements and Antheia's quality standards.
• Conduct qualification, onboarding, and periodic re-qualification audits of CMO partners globally, including API manufacturers and RSM suppliers in North America, Europe, and Asia.
• Review and approve CMO batch records, deviation notifications, change controls, and annual product reviews; serve as the primary Quality escalation point for CMO-related issues.
• Develop and maintain CMO quality oversight metrics and scorecards; drive performance improvement initiatives where gaps are identified.
• Coordinate joint investigations with CMO partners for complex events, ensuring Antheia interests and regulatory obligations are fully protected.
• Support CMO technology transfers by providing quality guidance during process establishment, validation, and initial commercial production at contract sites.

Regulatory Compliance & Agency Interactions

• Support global regulatory submissions (IND, NDA, MAA, DMF/ASMF) by providing quality sections, CMC data, and site information pertaining to RSM and API manufacturing.
• 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.
• Prepare and review inspection responses, commitments, and CAPAs resulting from regulatory agency observations.
• Maintain current knowledge of evolving GMP regulations, ICH guidelines, and DEA requirements relevant to controlled substance API and RSM manufacturing; communicate changes and impact assessments to leadership.

Quality Systems & Continuous Improvement

• Champion the development, implementation, and continuous improvement of Antheia's global QMS, ensuring harmonization across internal and CMO sites.
• Define and monitor quality performance metrics (KPIs) for both direct and contract manufacturing; present trends and improvement plans to senior leadership.
• Drive risk management activities in accordance with ICH Q9, identifying and mitigating quality risks across the supply chain.
• Lead or support cross-functional continuous improvement projects aimed at improving product quality, process robustness, and QMS efficiency.
• Build and maintain an effective supplier quality program in partnership with Supply Chain, qualifying key RSM and excipient suppliers and overseeing supplier audit programs.
• Support the implementation and optimization of quality systems infrastructure including QMS software, ERP integrations, and electronic batch recording.

Leadership & Team Development

• Recruit, develop, and mentor Quality staff supporting both direct and CMO manufacturing operations; foster a culture of quality accountability and continuous learning.
• Define functional responsibilities and growth paths for the Global Quality team in alignment with company stage and strategic goals.
• Act as a Quality thought leader and cross-functional collaborator, representing quality interests in project teams, steering committees, and executive briefings.
• Support and, at times, lead broader departmental initiatives as delegated by the SVP of Quality Assurance & Regulatory Affairs.
• Perform other duties as assigned^[i]

Qualifications 

• 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.
• Demonstrated experience in both direct manufacturing quality oversight and CMO/third-party quality management, including quality agreement development and supplier auditing/oversight.
• Proven track record of leading GMP investigations (deviation, OOS/OOT, CAPA) with verifiable root cause analysis and sustainable corrective actions.
• 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.

Preferred

• 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, TrackWise, Master Control or equivalent).
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.

Additional Information:  

•  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.
• Opportunity for this position to be fully remote if outside of California, but prefer a hybrid role in the Menlo Park, CA headquarters. 

[1] This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

Please note that Antheia doesn't discriminate based on age, race, ethnicity, national origin, religion, gender, sexual orientation, disability, medical history, and other non-merit characteristics.