The Manager, Manufacturing Product Quality (Small molecule) is responsible for ensuring GMP and GCP compliance in the manufacturing packaging, labeling, and distribution of commercial and clinical trial materials across global operations. This role supports the oversight of manufacturing and packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the commercial and clinical supply chains.
The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Supply Chain to ensure the integrity and traceability of investigational products from manufacturing and packaging through delivery.
Key Responsibilities
Oversee manufacturing of commercial and clinical products at contract manufacturers to ensure compliance with GMP, GCP, and applicable global regulatory requirements.
Performs batch record review and quality release activities of assigned commercial and clinical products (API, drug product, and final finished product).
In collaboration with the supplier quality team, support qualification and monitoring of external contract manufacturing vendors, including audits and performance reviews.
Review and approve GMP documentation including batch records, labels, and packaging specifications.
Ensure proper implementation of manufacturing, packaging and labeling requirements for commercial products and investigational products across global clinical trials.
Provides quality oversight for QC- related activities including review and approval of release/stability data, method development and validation, testing protocols/reports, method transfers and testing activities.
Collaborate with Commercial and Clinical Supply Chain and Regulatory Affairs to ensure timely and compliant delivery of clinical materials.
Support deviation investigations, CAPA implementation, and change control related to manufacturing activities.
Maintain and update SOPs, work instructions, and quality documentation related to manufacturing and packaging processes
Collaborates with cross functional teams to prepare of the Annual Product Quality Review (APQR) for commercial products.
Provide training and guidance to internal teams and external partners on quality requirements.
Participate in periodic reviews of quality systems and contribute to improvement initiatives.
Prepare and contribute to quality metrics and reports for management review.
Qualifications
Required
Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field.
Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in Quality Assurance or Supplier Quality roles.
Familiarity with FDA 21 CFR Parts 210, 211, 820, and Part 11 requirements.
Strong organizational and communication skills.
Ability to manage multiple tasks and work collaboratively in a team environment.
Proficiency in MS Word, Excel, and Access; experience with quality systems (e.g., TrackWise) is a plus.
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 $107,718.00 - Maximum $161,000.00, 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 (EEAccommodations@otsuka-us.com) .
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