The Manager, Global Product Quality, R&D develops, implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP Suppliers that are utilized in the development, clinical manufacturing, clinical packaging, labeling, testing (release & stability) and distribution of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) R&D products.
Works 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 and ensure compliance with regulatory requirements and Otsuka Policies and Procedures.
Responsible for the day-to-day Quality Oversight of assigned GMP Suppliers.
Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies.
Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies.
Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Provides Quality Oversight of quality system records to ensure their timely initiation, execution and closure.
Provides Quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability).
Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities.
Manages and/or supports the OPDC Clinical Product Quality Complaints Program ensuring that U.S. clinical product quality complaints are documented, coordinated, investigated, resolved, and closed out in a uniform, compliant and timely manner.
Ensures PQCs are trended to ensure early detection of potential quality issues.
Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures.
Conducts audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements.
Participates in internal audits.
Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products.
Performs quality reviews of CMC sections of regulatory submissions.
Works collaboratively with local and global Otsuka departments if a clinical stock recovery (recall) of Investigational Medicinal Product is required.
Authors and maintains Standard Operating Procedures, Working Practices and Job Aids.
Works collaboratively within the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements.
Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements.
Maintains GMP records (document storage, archiving, retrieval)
* Note: Manager may or may not have Direct Reports.
Bachelor's degree in Chemistry, Biology, Engineering or related Science
3-6 years of combined experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products.
1-2 years of supplier quality experience in managing GMP suppliers (or experience in internal/external auditing).
Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional and effective manner.
Ability to manage and prioritize multiple tasks
Experience in using MS Office (Word, Excel, PowerPoint)
Experience in using TrackWise.
Excellent interpersonal and communication skills
Technical Writing Experience: writing Investigations and performing root cause analysis.
Thorough understanding of GMP requirements and the Drug Development process.
Knowledge of FDA 21 CFR Parts 210 and 211
Analytical problem solving and decision-making skills.
Ability to identify gaps/risks and propose corrective and preventative actions.
Position requires approximately 25% domestic travel; Occasional international travel may also be expected
ASQ Certification or equivalent
Experience in Clinical Packaging/Clinical Supplies Operations.
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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