Role summarythe senior manager, quality audits is responsible for leading and executing internal and external audits across acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with gmp and gxp regulations, maintaining robust quality agreements, and supporting the ongoing effectiveness and continuous improvement of acadia’s quality management system. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations. This position can be based in san diego, ca or princeton, nj or san francisco, ca. Acadia's hybrid model requires this role to work in our office three days per week on average.responsibilitiesplan, coordinate, schedule, and conduct internal and external gmp/gxp compliance audits, ensuring csps meet acadia standards and all applicable fda, eu (eudralex), canadian, and international regulatory requirementsprepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management reviewdevelop, review, negotiate, and maintain quality agreements with clinical and commercial cspsmaintain and continuously improve the internal audit program, including coordination of gxp audit activities with internal and external stakeholdersprepare, review, format, and maintain sops, and recommend or implement policy and procedural changes that may impact departmental or company-wide operationsprovide gmp compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall eventssupport the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including csv support as neededlead and support continuous improvement initiatives aligned with gmp and industry best practices, while ensuring compliance with company policies, including privacy/hipaa and other legal requirementsother duties as assignedqualificationsbachelor’s degree in a life sciences or related field. An equivalent combination of education and applicable job experience may be considered.targeting 6 years of progressively responsible experience within quality assurance (qa), including 3 years directly responsible for gmp qa, with knowledge of external and internal auditing.extensive knowledge of guidelines and international regulations that affect the gmp qa programs.asq or eca academy certification, and/or european lead auditor experience is a plus.skillsin-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industrydemonstrated expertise in qa activities and gmp regulations (fda, eu, ich) across clinical development, manufacturing, technology transfer, and commercial operationsstrong ability to interpret and apply u.s. and international cgmp requirementsproven experience conducting internal audits, supplier audits, and manufacturing site inspectionsability to translate quality standards into practical implementation and review activitiesclear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiencesstrong collaboration skills with the ability to influence and gain cooperation across functionswillingness to travel domestically and internationally (approximately 25–30%)educationbachelor’s degree in a life sciences or related field. An equivalent combination of education and applicable job experience may be considered.additional requirementstravel domestically and internationally (approximately 25–30%)
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