Senior Manager, Global Supplier Quality

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 135,000 - 201,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Prescription drug coverage

Basic life insurance

AD&D insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Other benefits

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Manager of Global Supplier Quality to oversee supplier quality management for global development and commercial operations.

You will provide technical support for supplier qualification, audits, risk management, and oversight, partnering with cross‑functional stakeholders to strengthen processes and manage quality risks. You will drive supplier governance, review audit outcomes, CAPA plans, and regulatory inspection readiness, while leading

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, or another scientific discipline.
• Minimum of 6 years of progressive QA, supplier, external manufacturing, or quality systems experience in pharma/biotech/medical devices.
• Minimum of 3 years independently planning, conducting, and leading GMP audits of external suppliers.

Responsibilities

• Oversee supplier quality activities for strategic/high‑risk suppliers supporting commercial and development ops.
• Collaborate with Procurement, Supply Chain, Manufacturing, R&D, Regulatory, and Quality to support supplier lifecycle activities.
• Review audit reports and CAPA plans to ensure observations are addressed and compliance maintained.
• Manage supplier performance reviews, risk assessments, and escalation of significant quality risks as needed.
• Lead continuous improvement initiatives to strengthen supplier quality processes and audit effectiveness.

Skills

Quality Assurance

GMP Audits

Supplier Quality

Regulatory Knowledge

Cross-functional Collaboration

Travel up to 50%

Education

Science degree

Tools

TrackWise Digital

GxP systems

Job description

The Senior Manager of Global Supplier Quality is responsible for supplier quality management activities that ensure the quality, compliance, performance, and reliability of external suppliers supporting Otsuka’s global development and commercial operations. This role provides technical support for supplier qualification, supplier auditing, supplier risk management, and ongoing supplier oversight activities while partnering with cross-functional stakeholders to strengthen supplier quality processes, proactively manage supplier quality risks, and support continuous improvement across the Global Supplier Quality program.

Key Responsibilities

Supplier Oversight & Relationship Management

• Support quality oversight activities for strategic and high-risk suppliers supporting commercial and development operations.
• Partner with Procurement, Supply Chain, Manufacturing, Technical Operations, Regulatory Affairs, and Quality organizations to support supplier lifecycle activities.
• Support supplier governance activities through routine quality interactions, supplier performance reviews, and risk assessments.
• Build collaborative relationships with suppliers while maintaining compliance with Otsuka quality standards and applicable regulatory requirements.

Supplier Auditing & Compliance

• Support domestic and international GMP audits of contract manufacturers (CMOs/CDMOs), contract laboratories, API manufacturers, packaging suppliers, distributors, and other outsourced GxP service providers.
• Support execution of the global supplier audit program to ensure timely completion of risk-based supplier audits.
• Review audit reports to ensure consistency, technical accuracy, and compliance with established audit procedures.
• Review supplier responses and CAPA plans to ensure audit observations are effectively addressed.
• Support evaluation of supplier quality issues and recommend actions to management.
• Support regulatory inspections and inspection readiness activities involving supplier quality.

Supplier Performance & Risk Management

• Monitor supplier quality performance and identify emerging trends and quality risks.
• Support development and reporting of supplier quality metrics and key performance indicators.
• Recommend actions to mitigate supplier quality risks and improve supplier performance.Escalate significant supplier quality risks and compliance concerns, as appropriate.

Operational Excellence

• Recommend continuous improvement initiatives that strengthen supplier quality processes, audit effectiveness, and operational efficiency.
• Support optimization of electronic Quality Management Systems, including TrackWise Digital.
• Support development and revision of supplier quality procedures, work instructions, templates, and training materials.
• Identify opportunities to improve consistency across supplier quality processes and audit activities.

Leadership

• Provide guidance and support to colleagues and auditors within assigned areas of expertise.
• Participate in and support cross-functional projects and supplier quality initiatives.
• Develop and maintain expertise in supplier auditing, supplier risk management, and external supplier oversight.
• Contribute to knowledge sharing, and continuous improvement across the Global Supplier Quality organization.

Qualifications

Required

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, or another scientific discipline.
• Minimum of 6 years of progressive experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, Manufacturing Quality, or Quality Systems within the pharmaceutical, biotechnology, or medical device industry.
• Minimum of 3 years of experience independently planning, conducting, and leading GMP audits of external suppliers.
• Strong knowledge of FDA, EMA, ICH, and other applicable global GMP regulations.
• Experience leading complex supplier quality activities including supplier qualification, supplier oversight, audit observations, CAPA management, supplier risk assessments, and supplier performance monitoring.
• Demonstrated ability to support supplier activities, collaborate with cross-functional stakeholders, and contribute to quality improvement activities.
• Strong communication, analytical, organizational, and problem-solving skills with the ability to influence cross-functional stakeholders.
• Ability to travel domestically and internationally, up to 50%.

Preferred

• ASQ Certified Quality Auditor (CQA), Lead Auditor certification, or equivalent.
• Experience supporting commercial and development-stage pharmaceutical products.
• Experience utilizing TrackWise Digital.
• Experience supporting regulatory inspections and supplier remediation activities.
• Experience developing or improving supplier quality processes, supplier audit programs, or supplier governance activities.

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.

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.

Application Deadline

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

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 [e-mail].

Minimum $134,615.00 - Maximum $201,250.00, 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.

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