Associate Director, Global Quality Operations

Job Summary

The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization. This role is instrumental in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals.

Job Description

Operational Excellence

• Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance.

• Identify and implement best practices, metrics, and tools to drive performance and accountability.

• Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment.

• Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives.

Risk Management

• Develop and maintain a proactive quality risk management framework aligned with ICH Q9 principles.

• Conduct risk assessments for quality processes, systems, and operations, and support mitigation planning.

• Monitor and report on key risk indicators and escalate critical risks to senior leadership.

Global Quality System Processes

• Oversee the design, implementation, and maintenance of global quality system processes (e.g., deviation management, CAPA, change control, document management) guided by process excellence principles.

• Ensure harmonization and standardization of quality processes across sites and regions.

• Support quality system enhancements and digital transformation initiatives, ensuring they are informed by robust business process design and governance practices.

Compliance & Governance

• Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards.

• Support internal audits and regulatory inspections, including readiness activities and remediation.

• Analyze, monitor, and maintain KPIs and dashboards to identify trends, root causes, and opportunities for continuous improvement.

Leadership & Collaboration

• Serve as a technical leader within a matrixed organization.

• Collaborate with Supply Chain, Regulatory Affairs, IT, and other functions to ensure integrated quality operations.

• Align process improvement initiatives with strategic goals and support leadership in prioritizing efforts that deliver the greatest organizational impact.

• Represent Quality Operations in global forums and strategic planning initiatives.

Qualifications

Required

• Bachelor's degree in life sciences, engineering, or related field; advanced degree preferred.

• 8+ years of experience in pharmaceutical quality operations, with exposure to both small molecule and biologics.

• Strong knowledge of GxP regulations, quality systems, and risk management principles.

• Proven experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).

• Excellent communication, leadership, and project management skills.

• Ability to work in a global, matrixed environment and manage multiple priorities.

Preferred

• Experience with global quality systems platforms (e.g., Veeva, TrackWise).

• Familiarity with digital transformation and data analytics in quality operations.

• Prior involvement in regulatory inspections and audit readiness.

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 $150,034.00 - Maximum $224,250.00, 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; .

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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