Otsuka Pharmaceutical Companies (U.S.) · 3 weeks ago
Senior Manager, Quality Control, (Biologics)
Otsuka Pharmaceutical Companies (U.S.) is a prominent organization in the pharmaceutical industry, and they are seeking a Senior Manager, Quality Control (Biologics). This role involves overseeing QC activities across CDMOs and contract testing labs, ensuring compliance with regulatory standards, and supporting global regulatory filings.
HealthcareHealth CareMedical
Comp. & BenefitsH1B Sponsor Likely
Responsibilities
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
Qualification
Required
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
And paid leave programs as well as other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
Develops and commercializes innovative healthcare products.
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
31%
Represents job field similar to this job
Engineering and Development
Management and Executive
Product Management
Accounting and Finance
Marketing
Sales
Customer Service and Support
Trends of Total Sponsorships
*2026 (3)
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
John Kraus
Executive Vice President, Chief Medical Officer
Recent News
2026-03-25
Company data provided by crunchbase