Manager, Manufacturing Product Quality – Small Molecule

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Oversee manufacturing of commercial and clinical products at contract manufacturers for GMP and global regulatory compliance • Perform batch record review and quality release activities for API, drug product, and final finished product • Support qualification and monitoring of external contract manufacturing vendors, including audits and performance reviews • Review and approve GMP documentation, including batch records, labels, and packaging specifications • Ensure manufacturing, packaging, and labeling requirements are implemented across commercial products and global clinical trials • Provide quality oversight for QC activities, including release/stability data, method development and validation, testing protocols/reports, method transfers, and testing • Collaborate with Commercial and Clinical Supply Chain and Regulatory Affairs on compliant delivery of clinical materials • Support deviation investigations, CAPA implementation, and manufacturing-related change control • Maintain and update SOPs, work instructions, and quality documentation for manufacturing and packaging processes • Collaborate with cross-functional teams to prepare the Annual Product Quality Review for commercial products • Provide training and guidance to internal teams and external partners on quality requirements • Participate in quality-system reviews and improvement initiatives • Prepare and contribute to quality metrics and management reports

🎯 Requirements

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field • Minimum 5+ years of experience in a regulated industry, pharmaceutical or medical device • 3–5 years of experience in Quality Assurance or Supplier Quality roles • Familiarity with FDA 21 CFR Parts 210, 211, 820, and Part 11 requirements • Strong organizational and communication skills • Ability to manage multiple tasks and work collaboratively in a team environment • Proficiency in MS Word, Excel, and Access • Experience with quality systems such as TrackWise is a plus • Ability to travel up to 20%

🏖️ Benefits

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term disability insurance • Long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits