Senior Manager, Quality Control; Biologics

The Senior Manager, Quality Control (Biologics) will execute and support QC activities across CDMOs and contract testing labs within a virtual operating model, ensuring all analytical testing for biologics drug substance and drug product meets cGMP, regulatory, and company standards. This role is responsible for overseeing QC interface with external partners, supporting execution of analytical strategy, method lifecycle management, and data integrity.

It also supports global regulatory filings (IND/BLA/MAA) by delivering submission‑ready analytical strategies aligned with global expectations.

• 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.

• 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.

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long‑term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work…