Senior Manager, Global Quality Management - Clinical

Otsuka Pharmaceutical Co., Ltd.

8d • $131,153 - $196,075

About The Position

The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle.

Requirements

• Bachelor’s degree in life sciences or related field; advanced degree a plus.
• 6–8 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry.
• Solid understanding of GCP, ICH guidelines, and global regulatory requirements.
• Experience supporting inspection readiness and participating in audits or inspections.
• Strong communication, organizational, and problem-solving skills.
• Ability to travel domestically and internationally as needed.
• Proficiency in MS Office (Word, Excel, PowerPoint).

Nice To Haves

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

Responsibilities

• Clinical Study Support Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out.
• Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance.
• Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance.
• Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle.
• Inspection Readiness Support inspection readiness activities including mock audits, documentation reviews, and training coordination.
• Maintain inspection readiness tools, trackers, and communication plans.
• Participate in regulatory inspections and assist in preparing response documentation.
• Audit Program Execution Contribute to the development of the annual audit plan using risk-based approaches.
• Coordinate and support investigator site, vendor, and internal process audits.
• Track audit findings and ensure timely implementation of corrective and preventive actions (CAPAs).
• Monitor audit trends and escalate recurring issues to senior leadership.
• Quality Systems & Compliance Support the implementation and continuous improvement of clinical quality systems, SOPs, and policies.
• Assist with deviation management, root cause analysis, and CAPA tracking related to clinical activities.
• Stay current with evolving global GCP regulations and industry best practices.
• Collaboration & Team Support Partner with internal stakeholders and CROs to ensure consistent quality oversight.
• May mentor junior staff or contractors.
• Contribute to cross-functional initiatives that promote a culture of quality and compliance.

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: Senior
• Number of Employees: 1,001-5,000 employees