Manager, Global Quality Management – Clinical Audit

Global Quality Audit Manager

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.

• 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.

Required

• 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%.
• Preferred:
• Familiarity with Track Wise or similar quality management systems.
• Experience working with CROs or external vendors.
• Exposure to FDA or other health authority inspections.

Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving – Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication – Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development – Play an active role in professional development as a business imperative.

Minimum $ – Maximum $, plus incentive opportunity:
The range shown represents a typical pay range or starting pay for individuals who are hired in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum.

This information is provided to applicants in accordance with states and local laws.

This will be posted for a minimum of 5 business days.

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition…