Senior Manager, Global Quality Management - Clinical

Senior Manager Of Global Quality Management

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

Audit Program Execution

Quality Systems & Compliance

Collaboration & Team Support

Qualifications

Required

Preferred

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.

Salary Range : 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.

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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