Otsuka Pharmaceutical Companies (U.S.) · 4 days ago
Senior Manager, Global Product Quality - Biologics
United States
Full-time
Remote
Mid, Senior Level
$131K/yr - $196K/yr
4+ years expOtsuka 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.
Health CareMedical
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
Qualification
Required
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
Preferred
Experience with quality oversight of controlled substances
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
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
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2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
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