The Director, Global Product Quality – Manufacturing Product Quality leads the quality oversight of clinical and commercial products at CDMOs 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 cGMP/GDP quality standards. This role has global responsibility for clinical and commercial product quality to ensure stabile supply for Otsuka’s patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support clinical studies and commercial operations as well as drive continuous improvement.
Key Job Responsibilities
• Responsible for overall Quality and compliance of GMP suppliers providing contract manufacturing, clinical packaging and labeling, distribution, and testing services for Otsuka Small Molecule and Biologics products
• Establishes and maintains the effectiveness of Quality Systems for managing the batch record review and disposition processes supporting Commercial Product (API, drug product, and final finished product)
• Works to maintain the effectiveness of Quality Management Systems for GMP activities supporting Investigational Medicinal Products and Commercial Product
• Leads resolution of product quality issues by driving robust root cause investigations and CAPA implementation and escalates quality issues to senior management when appropriate
• Oversees development and maintenance of Standard Operating Procedures, work instructions, forms, templates, and other documents associated with the systems noted above
• Ensures Quality Agreements are executed with Suppliers and that the agreements remain in compliance with local and global procedures
• Represents global product quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP
• Collaborates with project teams supporting key Otsuka projects to assure that goals set by the team as they relate to potential suppliers are consistent with local and global quality objectives and relevant governmental requirements
• Serves as Global Quality Product Champion and is responsible for monitoring and escalation of any situation with potential negative impact on clinical study supplies and/or supply chain for commercial product or impact to patients
Knowledge, Skills, Competencies, Education, and Experience
Required:
• Bachelor’s degree in Biology, Chemistry, or related field
• Minimum 12 years of combined experience in QA role and/or pharmaceutical manufacturing role, supporting GMP activities for Investigational Medicinal Products or Commercial Products
• Thorough understanding of the Drug Development process and cGMP regulatory requirements
• Ability to handle interactions and resolve issues with internal customers and GMP Suppliers in a tactful, professional and effective manner
• Experience with Small Molecule API and Drug Product manufacturing
• Strong analytical problem solving and decision-making skills
• Risk Management experience
• Position requires approximately 30% domestic travel; Occasional international travel may also be necessary
Preferred:
• Advance degree in Biology, Chemistry, or related field
• Experience with medical devices/combination products
At least 8 years of Quality Management experience
Experience with Biologics manufacturing
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 $169,222.00 - Maximum $253,000.00, 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
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 employerAll 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
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There are two Otsuka pharmaceutical industry companies in the U.S.:
Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.
