Senior Manager, Quality Control, Biologics

🕒 July 1

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 QC activities across CDMOs and contract testing labs within a virtual operating model • Ensure all analytical testing for biologics drug substance and drug product meets cGMP, regulatory, and company standards • Oversee QC interface with external partners • Support execution of analytical strategy, method lifecycle management, and data integrity • Support global regulatory filings (IND/BLA/MAA) • Coordinate and support QC activities at CDMOs and contract laboratories to ensure alignment with established plans • Review and approve analytical data for in-process, release, and stability testing • Ensure adherence to quality agreements, regulatory requirements, and company standards • Track and report CDMO performance using KPIs (on-time release, deviations, right-first-time execution) • Lead method transfer, qualification, validation, and lifecycle management • Execute and monitor methods to ensure robust, phase-appropriate, and compliant • Provide technical leadership for investigations, troubleshooting, and assay optimization • Support comparability strategies, method improvements, and continuous verification through data analysis and evaluation • Perform independent review of analytical data, CoAs, and trend reports • Support batch disposition decisions in collaboration with QA • Ensure ALCOA+ data integrity across all partners • Review and approve deviations, OOS/OOT investigations, CAPAs, and change controls • Ensure compliance with cGMP, ICH, USP/EP, and global regulatory standards • Oversee stability programs at CDMOs, including data review, trending, and shelf-life justification • Support audits, inspections, and vendor qualification activities • Support QC contributions to IND, BLA, MAA, and lifecycle submissions • Author and review Module 3 (CMC) sections, ensuring alignment with regulatory expectations • Support preparation of submission-ready documentation, analytical methods, specifications, validation, and comparability strategies • Coordinate CDMO data packages to ensure audit-ready regulatory submissions • Support health authority interactions, including responses to queries and pre-approval inspections (PAIs) • Contribute to post-approval lifecycle activities (supplements, variations, annual reports) • Partner with Analytical Development, QA, Regulatory Affairs, CMC, and Supply Chain to align QC strategy with development and commercialization goals.

🎯 Requirements

• Ph.D., MS, or BS in Biochemistry, Molecular Biology, Biotechnology, or related field • 8-10 years of experience in biologics QC, Analytical Development, or Quality • Strong experience working in a virtual biotech/pharma model managing CDMOs and contract labs • Proven track record supporting global regulatory filings and inspections • Extensive experience with IND, BLA, MAA, and post-approval submissions (PAS, CBE-30, variations, annual reports) • Demonstrated expertise in Module 3 (CMC) authoring and analytical control strategies • Strong knowledge of analytical methods, validation, comparability, and stability requirements • Ability to integrate data from multiple CDMOs into cohesive, audit-ready submission packages • Experience responding to health authority queries and supporting pre-approval inspections • Strong focus on data integrity, traceability, and inspection readiness.

🏖️ 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