Senior Manager, Global Quality Management - Clinical

Job Summary

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.

Key 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.

Qualifications

Required

• 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).

Preferred:

• Experience with TrackWise or similar quality management systems.

• Prior collaboration with CROs and external vendors.

• Exposure to FDA or other health authority inspections.

Competencies

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 $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform 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.

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

Company 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.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .

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