Senior Level Quality Control Technician Jobs

INTRODUCTION

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, support 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.

ROLE AND 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.

BASIC QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

Competencies

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 toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

COMPENSATION

• Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

APPLICATION DEADLINE

This will be posted for a minimum of 5 business days.

COMPANY 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.

Come discover more about Otsuka and our benefit offerings.

DISCLAIMER:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

STATEMENT REGARDING JOB RECRUITING FRAUD SCAMS

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

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Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.