Associate Director of Global Quality

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

Benefits

Additional Information

About Antheia: Antheia is the advanced biosynthesis company transforming pharmaceutical manufacturing and innovation for the 21st century. Antheia's commercially proven technology platform produces high-value pharmaceutical ingredients in a fraction of the time compared to legacy approaches while significantly reducing supply chain risk. 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. Backed by leading investors and recognized by the U.S. government as a priority technology for public health and national and economic security, Antheia is manufacturing the medicines the world needs today while enabling tomorrow's breakthrough therapeutics. Working at Antheia: 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. As a team, we aim to embody a culture that celebrates diversity, prioritizes knowledge sharing, encourages exploration and ideation, challenges constructively, and supports individuals in their professional and personal journeys. At Antheia, you can expect to be inspired by the science, by your teammates, and by the opportunity we have to bring about change in the pharmaceutical industry. 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.

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