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The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka’s patients.

Job Description

+ Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities.

+ Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers.

+ Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products.

+ Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply.

+ Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure.

+ Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability).

+ Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities.

+ Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures.

+ Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements.

+ Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions.

+ Authors and maintains Standard Operating Procedures, Working Practices and Job Aids.

+ Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements.

+ Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements.

Qualifications

Required

+ Bachelor’s degree in Chemistry, Biology, Engineering or related Science.

+ Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products.

+ Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing).

+ Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing.

+ Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner.

+ Experience in using MS Office (Word, Excel, PowerPoint).

+ Experience in using TrackWise.

+ Excellent interpersonal and communication skills.

+ Technical Writing Experience: writing Investigations and performing root cause analysis.

+ Thorough understanding of GMP requirements and the Drug Development process.

+ Knowledge of FDA 21 CFR Parts 210 and 211.

+ Experience with Pre Approval Inspections for NDAs and BLAs.

+ Analytical problem solving and decision-making skills.

+ Ability to identify gaps/risks and propose corrective and preventative actions.

+ Position requires approximately 20% domestic travel; Occasional international travel may also be expected.

Preferred

+ Experience with quality oversight of controlled substances.

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.

Minimum $131,153.00 - Maximum $196,075.00, 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; https://www.otsuka-us.com/careers-join-otsuka .

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 ([email protected]) .

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