Antheia

Antheia

Associate Director of Global Quality

Menlo Park, CA · Director · Full-time

Sponsorship not specified$10k-$15kDetected 36 days ago
ComplianceSAPAuditingSupply ChainERPPublic HealthGMPFDA RegulatoryLeadershipCommunicationInternal AuditFermentationRegulatory Affairs

About the role

  • About Antheia: Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century.
  • 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.
  • Reporting to the SVP of Quality Assurance & Regulatory Affairs, the Associate Director of Global Quality is a critical member of the Quality leadership team.

Responsibilities

  • Create processes for and then execute the review, approval, and release of batch production and control records
  • 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.
  • 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.
  • Develop and maintain CMO quality oversight metrics and scorecards
  • 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.
  • 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.

Requirements

  • 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.
  • 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.
  • 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.
  • Experience with international CMO networks spanning North America and Europe.
  • BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
  • 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.
  • Exposure to regulated starting material (RSM) designation under ICH Q11 and the associated regulatory strategy considerations.

Compensation

  • Opportunity for this position to be fully remote if outside of California, but prefer a hybrid role in the Menlo Park, CA headquarters.
  • Review and approve CMO batch records, deviation notifications, change controls, and annual product reviews

Benefits

  • Our cross-functional team shares a vision for the future: improved pharmaceutical supply chains that can end drug shortages and drive equitable access to essential medicines.
  • Full-time base salary range of $156,000 - $220,000 plus an annual bonus potential and equity opportunities.

Company info

  • The company provides its global pharmaceutical customers with a resilient, efficient supply of critical ingredients at scale, while expanding the innovation frontier for new therapeutic development.
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This listing is sourced directly from Antheia's careers page and normalized into a canonical job model.