Manager, Global Quality Management - Clinical Audit

Otsuka Pharmaceutical Co., Ltd.

8d

About The Position

The Global Quality Audit Manager is responsible for planning, executing, and reporting on global audits to ensure Good Clinical Practice (GCP) compliance across Contract Research Organizations (CROs), clinical laboratories, and clinical investigator sites. This role plays a critical part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous improvement, and support inspection readiness across the clinical research landscape.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field; advanced degree preferred.
• 3 -5 years of experience in clinical quality assurance or GCP auditing within the pharmaceutical, biotech, or CRO industry.
• In-depth knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements related to clinical research.
• Experience auditing CROs, investigator sites, and clinical laboratories.
• Strong analytical, organizational, and communication skills.
• Ability to work independently and manage multiple audits across global regions.
• Proficiency in audit management systems and Microsoft Office tools.
• Willingness to travel internationally up to 20%.

Nice To Haves

• Familiarity with TrackWise or similar quality management systems.
• Experience working with CROs or external vendors.
• Exposure to FDA or other health authority inspections.

Responsibilities

• Audit Execution: Plan, conduct, and report GCP audits of CROs, clinical laboratories, and investigator sites globally, ensuring compliance with ICH-GCP, local regulations, and company policies. Provide oversight to contract and consultant resources in audit conduct and reporting.
• Risk-Based Audit Planning: Support the development and maintenance of a global audit schedule based on risk assessments, regulatory requirements, and business priorities.
• Audit Reporting & Follow-Up: Document audit findings, issue formal reports, and ensure timely follow-up and closure of corrective and preventive actions (CAPAs).
• Stakeholder Engagement: Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other functions to ensure alignment on quality expectations and audit outcomes.
• Continuous Improvement: Identify trends and systemic issues from audit findings and contribute to the development of global quality improvement initiatives.
• Training & Guidance: Provide GCP compliance training and guidance to internal teams and external partners as needed.
• Metrics & Reporting: Maintain audit metrics and contribute to management reporting on audit outcomes, trends, and compliance risks.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees