Role summarythe associate director, glp/gcp quality audits and compliance plays a critical role in protecting data integrity and regulatory readiness across the company’s nonclinical and clinical portfolio. This position leads the planning, execution, and reporting of internal and external glp/gcp audits, ensuring compliance with u.s. and international regulations while driving continuous improvement in quality systems. This role provides expert guidance on glp/gcp compliance, supports regulatory inspections, and works closely with internal teams and contract service providers (csps) to maintain inspection-ready operations. The position can be based in san diego, ca; princeton, nj; or san francisco, ca, with a hybrid model requiring in-office work three days per week on average.responsibilitiesplan, schedule, coordinate, and conduct internal and external glp/gcp and gcp audits of company functions and contract service providers (csps) in accordance with company standards and global regulatory requirementsown the end-to-end audit lifecycle, including audit preparation, execution, documentation, reporting, follow-up, and verification of corrective and preventive actionsprepare, review, and approve clear, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolveddevelop, review, and maintain glp/gcp quality agreements, sops, and related quality documentation supporting nonclinical and clinical activitiesmaintain, manage, and continuously improve the internal glp/gcp audit program, ensuring ongoing inspection readinesscompile, analyze, and trend audit metrics to support management review, quality oversight, and regulatory inspectionsserve as a glp/gcp subject matter expert, partnering with internal and external stakeholders to ensure consistent regulatory compliancesupport internal audits, mock inspections, and regulatory inspections, recommend policy and process improvements with company-wide impact, and ensure adherence to company policies, including privacy/hipaa and other applicable legal and regulatory requirementsother duties as assignedqualificationsbachelor’s degree in life sciences or a related scientific/technical discipline (equivalent combination of education and experience may be considered)8+ years of progressively responsible qa experience, including 5+ years directly responsible for glp/gcp qa, with direct experience leading external and internal auditsextensive knowledge of guidelines and international regulations affecting glp/gcp qa programscertification such as sqa, asq, or eca academy is a plus; european lead auditor experience is a plusskillsthorough knowledge of quality management practices in pharmaceutical, biopharmaceutical, or other regulated industriesexpertise in ich, fda, eu, and international glp/gcp regulations as they apply to nonclinical and clinical studiesability to interpret and apply glp/gcp regulations across u.s. and global requirementshands-on experience conducting internal audits, supplier audits, and inspections of laboratories, clinical operations, and manufacturing facilitiesability to translate quality standards into practical implementation, assess compliance, and drive continuous process improvementstrong communication skills to present technical and regulatory information across functions and stakeholder groupsability to align and coordinate resources, motivate teams, and achieve quality objectivesanalytical, planning, and negotiation skills with sound judgment on risk and compliance impactcollaborative approach with a proven ability to gain cooperation and influence outcomes without direct authoritywillingness to travel domestically and internationally (approximately 25–30%)educationbachelor’s degree in life sciences or related discipline (or equivalent)education and experience aligning with glp/gcp qa programs; professional certifications are a plusadditional requirementsregular in-office presence required three days per week as part of a hybrid arrangementtravel domestically and internationally as part of audits and regulatory inspectionsmust meet essential job functions, including ability to endure travel and occasional after-hours work as travel schedules demand
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