Senior Manager, Global Product Quality - Biologics

Otsuka Pharmaceutical Companies (U.S.) is a leading pharmaceutical company focused on improving the health of patients. They are seeking a Senior Manager, Global Product Quality - Biologics who will manage quality oversight of clinical and commercial products to ensure compliance with regulatory expectations and quality standards.

Responsibilities:

• Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities
• Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers
• 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 and commercial products
• 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 and commercial supply
• Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions 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
• Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures
• Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements
• 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
• Authors and maintains Standard Operating Procedures, Working Practices and Job Aids
• Works collaboratively within the Global Quality 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

Requirements:

• Bachelor's degree in Chemistry, Biology, Engineering or related Science
• Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products
• Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing)
• Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing
• Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner
• 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
• Experience with Pre Approval Inspections for NDAs and BLAs
• Analytical problem solving and decision-making skills
• Ability to identify gaps/risks and propose corrective and preventative actions
• Position requires approximately 20% domestic travel; Occasional international travel may also be expected
• Experience with quality oversight of controlled substances