Role summary
the 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.
responsibilities
* plan, 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 requirements
* own the end-to-end audit lifecycle, including audit preparation, execution, documentation, reporting, follow-up, and verification of corrective and preventive actions
* prepare, review, and approve clear, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolved
* develop, review, and maintain glp/gcp quality agreements, sops, and related quality documentation supporting nonclinical and clinical activities
* maintain, manage, and continuously improve the internal glp/gcp audit program, ensuring ongoing inspection readiness
* compile, analyze, and trend audit metrics to support management review, quality oversight, and regulatory inspections
* serve as a glp/gcp subject matter expert, partnering with internal and external stakeholders to ensure consistent regulatory compliance
* support 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 requirements
* other duties as assigned
qualifications
* bachelor'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 audits
* extensive knowledge of guidelines and international regulations affecting glp/gcp qa programs
* certification such as sqa, asq, or eca academy is a plus; european lead auditor experience is a plus
skills
* thorough knowledge of quality management practices in pharmaceutical, biopharmaceutical, or other regulated industries
* expertise in ich, fda, eu, and international glp/gcp regulations as they apply to nonclinical and clinical studies
* ability to interpret and apply glp/gcp regulations across u.s. and global requirements
* hands-on experience conducting internal audits, supplier audits, and inspections of laboratories, clinical operations, and manufacturing facilities
* ability to translate quality standards into practical implementation, assess compliance, and drive continuous process improvement
* strong communication skills to present technical and regulatory information across functions and stakeholder groups
* ability to align and coordinate resources, motivate teams, and achieve quality objectives
* analytical, planning, and negotiation skills with sound judgment on risk and compliance impact
* collaborative approach with a proven ability to gain cooperation and influence outcomes without direct authority
* willingness to travel domestically and internationally (approximately 25–30%)
education
* bachelor's degree in life sciences or related discipline (or equivalent)
* education and experience aligning with glp/gcp qa programs; professional certifications are a plus
additional requirements
* regular in-office presence required three days per week as part of a hybrid arrangement
* travel domestically and internationally as part of audits and regulatory inspections
* must meet essential job functions, including ability to endure travel and occasional after-hours work as travel schedules demand
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