Associate Director, Global Product Quality - Remote

Associate Director, Global Product Quality develops, implements, and maintains the quality systems and tools required to manage and monitor the quality and compliance aspects of company clinical and commercial products. They will lead the team of staff to provide all Quality support for clinical supply as well as commercial production and release.

Other responsibilities to include:

• Directs quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products
• 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
• Drafts and reviews Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met

• Establishes strategies to meet Quality Management Commercial business goals and partners with department leadership to ensure goals are met.
• Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting Commercial Product (API, drug product, and final finished product).
• Oversees Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above.
• Works collaboratively within the Quality Management Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance.
• Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests.
• Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above.
• Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting Commercial Products.
• Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations. OOS incidents, rejects, etc.
• Conducts audits of Contract Manufacturers/Laboratories (as part of an audit team) that support Commercial Products to ensure compliance with OAPI and OPDC requirements and applicable regulatory requirements.
• Interfaces with project teams supporting Commercial Products to assure that the goals set by the team as they relate to Contract Manufacturing/Laboratory Operations meet the required timelines and are consistent with OAPI quality objectives and relevant governmental requirements.

Required:

• Bachelor's degree in Chemistry, Biology or other Physical Sciences + 10 years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles supporting commercial product and development project activities.
• 10 years of supplier QA experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.
• 2years in leading cross functional teams and/or quality management group.
• Experience with Biologics GMP manufacturing as well small molecule manufacturing.
• Ability to supervise multiple direct reports and projects in a fast-paced environment.
• Ability to handle supplier audit situations and interactions in a tactful, professional and effective manner.
• Ability to manage and prioritize multiple tasks.
• Experience using MS Word, Excel, and Access.
• TrackWise Experience.
• Excellent interpersonal and communication skills.
• Travel (approximately 20%).

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 $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

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.

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