Associate Director, Global Supplier Quality

divh2Associate Director Of Global Supplier Quality/h2pThe Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the companys 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./ppSupport 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./ppEnsure 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./ppCollaborate 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. Track and report key performance indicators (KPIs) related to supplier quality. Provide regular updates to leadership on supplier performance and compliance status./ppMay supervise or mentor junior quality staff or contractors. Support continuous improvement initiatives within the supplier quality function./ppRequired: Bachelors 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./ppPreferred: Experience working with global CMOs. Familiarity with digital tools and systems for supplier management. Exposure to regulatory inspections and remediation activities./ppAccountability 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./ppMinimum $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 candidates 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./ppCompany 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./ppOtsuka 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)./ppStatement 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. 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 Otsukas 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./p/div