Associate Director, Global Product Quality - GMP Processes

Associate Director, Global Product Quality Gmp Process

The Associate Director, Global Product Quality Gmp Process is responsible for enabling the optimization and harmonization of key Gmp quality practices across the global organization. This role defines, maintains, and continuously improves critical quality system elements including Product Quality Complaints (Pqc), Corrective and Preventive Actions (Capa), Deviations, and Change Control, ensuring compliance with global regulatory requirements and internal standards. The successful candidate will lead cross-functional initiatives to enhance quality performance, reduce risk, and foster a culture of continuous improvement.

Key Responsibilities

Process Ownership & Governance :

• Lead the global strategy and governance for Product Quality Complaints, Capa, Deviations, and Change Control processes.
• Develop and implement global standards, procedures, and best practices to ensure consistency and compliance across all global affiliates.
• Partner with regional and site quality leaders to drive process improvements, enhance efficiency, and ensure alignment with corporate quality objectives.

Cross-functional Leadership :

Quality Strategy Development :

Inspection Readiness & Compliance :

Metrics and Reporting :

Training & Change Management :

Qualifications

Required :

Skills & Competencies :

Preferred Experience :

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 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.