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Associate Director, Global Product Quality
4 weeks ago
Associate Director Controlled Substances, Quality Global Product Quality - API/DPThe Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical and commercial controlled substances manufactured at CMOs under contract by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as controlled substances are manufactured, packed, labelled, stored, and transported in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement.Responsibilities include:Directing quality oversight of GMP contract manufacturers of controlled substances for Otsuka clinical and commercial productsSupporting cross-functional teams to ensure alignment and compliance with controlled substance regulationsProviding guidance and expertise to sites and business units to assess the facilities, and/or business operations, compliance of DEA regulations and site proceduresManaging, updating and improvements of corporate controlled substance oversight standardsEstablishing and maintaining the effectiveness of Quality Systems for managing the batch record review and release processWorking collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure compliance to ensure continuous improvement and complianceEstablishing and maintaining Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted aboveImproving supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial productsInterfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc.Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMPAssists in conducting audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable controlled substance regulatory requirementsResponsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously metQualifications:Required: Bachelor's degree in Chemistry, Biology or other Physical SciencesTen years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial and development controlled substances.Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.Expertise in conducting root cause investigations and driving CAPA implementationAbility to supervise multiple direct reports and projects in a fast-paced environmentDemonstrated success in working on and leading cross functional teamsExperience with Pre Approval Inspections for NDAsExperience in driving continuous improvement projectsTrackWise ExperienceExcellent interpersonal and communication skillsPosition requires approximately 20% domestic travel; Occasional international travel may also be expected.Preferred: Advanced degree in Chemistry or other Physical SciencesCompetencies:Accountability for ResultsStrategic Thinking & Problem SolvingPatient & Customer CentricityImpactful CommunicationRespectful CollaborationEmpowered DevelopmentCompensation: Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunityCompany benefits include 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 receive 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).Statement Regarding Job Recruiting Fraud Scams: 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.
