Otsuka is seeking a motivated, detail-oriented, and analytical professional to serve as the Manager, Global Supplier Performance & Metrics. Reporting directly to the Senior Manager, Global Supplier Performance & Metrics, this role is responsible for supporting the execution of supplier quality management activities to ensure the quality, compliance, and performance of external suppliers supporting Otsuka's global operations.
The Manager is responsible for the day-to-day execution of supplier performance monitoring, supplier quality oversight, KPI reporting, audit support, and supplier risk management activities. Working collaboratively with Global Quality, Technical Operations, Supply Chain, Regulatory Affairs, and external suppliers, this position helps maintain a robust supplier quality framework aligned with global GMP, GDP, and applicable regulatory requirements.
- Serve as the primary Quality representative for assigned suppliers, including CMOs, CDMOs, laboratories, packaging suppliers, and other GMP service providers.
- Participate in supplier governance meetings, Joint Steering Committees, and Business Review Meetings by preparing and presenting supplier quality performance data.
- Build collaborative working relationships with supplier quality personnel to facilitate timely communication, issue resolution, and continuous improvement.
- Identify and escalate supplier quality concerns, performance risks, and compliance issues to the Senior Manager with recommended actions.
- Collect, maintain, and analyze Global Supplier Quality metrics and key performance indicators.
- Develop and maintain supplier performance dashboards and scorecards supporting routine business reviews.
- Prepare recurring supplier performance reports, trend analyses, and management presentations.
- Monitor supplier performance data for emerging risks and support implementation of approved mitigation activities.
- Support the planning, coordination, and execution of supplier audits for API manufacturers, drug product CMOs, packaging suppliers, and contract laboratories.
- Monitor supplier CAPAs and follow up to ensure timely closure.
- Assist with drafting, revising, and maintaining supplier Quality Agreements.
- Support supplier qualification and ongoing supplier risk assessment activities.
- Serve as a functional user of TrackWise Digital supplier quality modules, maintaining supplier profiles, audit records, deviations, CAPAs, and supplier performance documentation.
- Ensure supplier quality records remain accurate, complete, and inspection-ready.
- Identify opportunities to improve supplier quality processes, reporting, and system utilization.
- Bachelor's degree in a scientific, engineering, or health-related discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) is required.
- Minimum of 3 years of progressive experience within the pharmaceutical, biotechnology, or medical device industry, with experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, or CMO Management.
- Previous experience supporting supplier quality programs, supplier audits, quality systems, or external manufacturing operations is preferred.
- Experience using TrackWise Digital or comparable electronic Quality Management Systems (eQMS) is required.
- Working knowledge of FDA 21 CFR Parts 210, 211, and 11, EU GMP, EudraLex Volume 4, and applicable ICH guidelines (Q7, Q9, and Q10).
- Experience participating in supplier audits and supporting risk-based supplier management activities.
- Strong analytical ability with experience interpreting supplier quality metrics and identifying performance trends.
- Effective written and verbal communication skills with the ability to prepare clear reports and present findings to cross-functional teams.
- Demonstrated ability to build productive working relationships with internal stakeholders and external suppliers.
- Strong organizational skills and the ability to prioritize multiple assignments while supporting continuous improvement initiatives.
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.
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.
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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 [email protected].
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Otsuka America Pharmaceutical Hayward, California, USA Office
Hayward, United States
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