Otsuka America Pharmaceutical Inc.
Associate Director, Global Supplier Quality
Otsuka America Pharmaceutical Inc., Boston, Massachusetts, us, 02298
The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company’s global network of contract manufacturing organizations (CMOs). This role supports the qualification, monitoring, and compliance of external manufacturing partners to ensure the quality and reliability of pharmaceutical products, including small molecules and biologics.
Job Description
Supplier Quality Execution
Support the qualification and ongoing monitoring of CMOs and critical suppliers.
Execute supplier audits and ensure timely follow-up and resolution of findings.
Maintain and update quality agreements in collaboration with internal stakeholders.
Conduct risk assessments and support mitigation plans for supplier‑related quality issues.
Compliance & Documentation
Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
Prepare documentation and support internal and external audits and inspections.
Maintain accurate records of supplier performance and audit outcomes.
Cross‑Functional Collaboration
Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality is integrated into business processes.
Serve as a point of contact for operational supplier quality issues and escalations.
Metrics & Reporting
Track and report key performance indicators (KPIs) related to supplier quality.
Provide regular updates to leadership on supplier performance and compliance status.
Team & Project Support
May supervise or mentor junior quality staff or contractors.
Support continuous improvement initiatives within the supplier quality function.
Qualifications Required
Bachelor’s degree in a scientific or engineering discipline.
6+ years of experience in pharmaceutical quality, with 2+ years in supplier or external manufacturing quality.
Strong knowledge of GMP regulations for small molecules and/or biologics.
Experience conducting audits and managing supplier documentation.
Strong communication and problem‑solving skills.
Ability to travel internationally as needed.
Preferred
Experience working with global CMOs.
Familiarity with digital tools and systems for supplier management.
Exposure to regulatory inspections and remediation 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.
Minimum $146,955.00 – Maximum $219,650.00, 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.
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 Accommodation Request (EEAccommodations@otsuka-us.com).
#J-18808-Ljbffr
Job Description
Supplier Quality Execution
Support the qualification and ongoing monitoring of CMOs and critical suppliers.
Execute supplier audits and ensure timely follow-up and resolution of findings.
Maintain and update quality agreements in collaboration with internal stakeholders.
Conduct risk assessments and support mitigation plans for supplier‑related quality issues.
Compliance & Documentation
Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
Prepare documentation and support internal and external audits and inspections.
Maintain accurate records of supplier performance and audit outcomes.
Cross‑Functional Collaboration
Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality is integrated into business processes.
Serve as a point of contact for operational supplier quality issues and escalations.
Metrics & Reporting
Track and report key performance indicators (KPIs) related to supplier quality.
Provide regular updates to leadership on supplier performance and compliance status.
Team & Project Support
May supervise or mentor junior quality staff or contractors.
Support continuous improvement initiatives within the supplier quality function.
Qualifications Required
Bachelor’s degree in a scientific or engineering discipline.
6+ years of experience in pharmaceutical quality, with 2+ years in supplier or external manufacturing quality.
Strong knowledge of GMP regulations for small molecules and/or biologics.
Experience conducting audits and managing supplier documentation.
Strong communication and problem‑solving skills.
Ability to travel internationally as needed.
Preferred
Experience working with global CMOs.
Familiarity with digital tools and systems for supplier management.
Exposure to regulatory inspections and remediation 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.
Minimum $146,955.00 – Maximum $219,650.00, 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.
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 Accommodation Request (EEAccommodations@otsuka-us.com).
#J-18808-Ljbffr