Senior Manager, Quality Control – Small Molecules

🕒 July 6

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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

• Execute and support the strategic and operational leadership for Quality Control activities supporting small‑molecule GMP manufacturing, product release, and regulatory compliance • Oversee QC laboratory operations, drug substance and drug product release, analytical characterization, and regulatory readiness while ensuring robust data integrity, inspection readiness, and continuous improvement across the product lifecycle • Manage day-to-day QC laboratory functions supporting small‑molecule drug substance (DS) and drug product (DP) release, including raw materials, in‑process testing, stability, and finished product testing • Ensure execution of analytical testing in compliance with cGMP, ICH Q2/Q6/Q7/Q10, USP/EP/JP, and internal SOPs • Review and analyze QC data (release, stability), and lifecycle metrics to support decision-making and identify trends • Provide scientific leadership for small‑molecule analytical characterization, including impurity profiling, degradants, residual solvents, elemental impurities, and solid‑state characterization (e.g., polymorphism) • Oversee analytical method transfer, validation, verification, and lifecycle management for DS and DP methods • Maintain continuous inspection readiness and support regulatory inspecting during FDA, EMA, and global authority inspections • Review and approve QC deviations, OOS/OOT investigations, CAPAs, and change controls related to analytical methods, specifications, and laboratory systems • Support IND, NDA, ANDA, and post‑approval submissions through preparation, review, and approval of QC sections and analytical data • Partner closely with Manufacturing, QA, CMC, Regulatory Affairs, and Supply Chain to support clinical and commercial supply • Support continuous improvement initiatives to enhance efficiency, automation, and digitalization initiatives

🎯 Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline (required) • Master’s degree or PhD preferred • 10+ years of experience in Quality Control or Analytical functions within small‑molecule pharmaceutical manufacturing • 5+ years of people management experience, including leading managers and technical teams • Experience with DS and DP release testing, analytical characterization, and QC support of regulatory filings • Strong understanding of small‑molecule analytical techniques (e.g., HPLC, GC, LC‑MS, FTIR, UV, dissolution) • Demonstrated experience supporting IND/NDA/ANDA filings and regulatory inspections • Deep knowledge of OOS/OOT management, CAPA, change control, and data integrity expectations

🏖️ 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 as well as other company provided benefits