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  1. Home
  2. chevron_right
  3. Healthcare & Nursing
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  5. Associate Director, Global Quality Operations
Otsuka America, Inc. logo

Associate Director, Global Quality Operations

Not Disclosed•Full-TimeOn-site

location_on2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States

Apply Now

About the Role

The Associate Director, Quality Operations serves as a strategic technical leader within our global quality organization. This role is instrumental in driving operational excellence, enhancing risk management practices, and optimizing quality system processes to ensure they are efficient, compliant, and aligned with our strategic business goals. You will lead initiatives that foster a culture of accountability and continuous improvement across a matrixed global environment.

In this position, you will act as a bridge between Quality Operations and key functions such as Supply Chain, Regulatory Affairs, and IT. Your day-to-day involves facilitating cross-functional collaboration to streamline end-to-end workflows, overseeing the harmonization of quality processes across sites, and supporting digital transformation initiatives. You will represent Quality Operations in global forums, ensuring that process improvement efforts deliver the greatest organizational impact while maintaining a steadfast focus on patient and customer centricity.

Our Culture and Values

At Otsuka, we are committed to empowering our employees to play an active role in their professional development as a business imperative. We value respectful collaboration, seeking diverse partnerships to enhance work toward common goals. Our leadership approach emphasizes impactful communication, where decisions are made with logic, clarity, and respect, considering the long-term impact on customers, patients, and the business.

Hiring Process and Application

This position will be posted for a minimum of 5 business days. We encourage all qualified applicants to apply through our official career website. Please note that Otsuka will never ask for financial information, payment of any kind, or the download of third-party applications during the job application process. If you are contacted regarding this opportunity, ensure you are communicating directly through official Otsuka channels.

Equal Opportunity and Accessibility

Otsuka is an equal opportunity employer. We encourage applications from all qualified individuals and provide consideration for employment without regard to race, color, sex, gender identity or 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 and require a reasonable accommodation to apply for this position, please contact Accommodation Request at EEAccommodations@otsuka-us.com.

Work location

Work model: On-site

location_on

2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States

Sacramento, California

Key Responsibilities

  • check_circleLead continuous improvement initiatives to enhance global quality efficiency and compliance
  • check_circleDevelop and maintain a proactive quality risk management framework aligned with ICH Q9 principles
  • check_circleOversee the design and maintenance of global quality system processes including deviation management and CAPA
  • check_circleEnsure quality operations comply with global regulatory requirements such as FDA and EMA standards
  • check_circleSupport internal audits and regulatory inspections including readiness activities and remediation
  • check_circleFacilitate cross-functional collaboration to streamline end-to-end workflows and optimize operational alignment
  • check_circleMonitor and report on key risk indicators and analyze KPIs to identify trends and improvement opportunities

Requirements

  • verifiedBachelor's degree in life sciences, engineering, or related field
  • verified8+ years of experience in pharmaceutical quality operations
  • verifiedStrong knowledge of GxP regulations
  • verifiedExperience with Lean or Six Sigma methodologies

Nice to Have

Advanced degree. 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.

Benefits & Perks

check_circleComprehensive medical, dental, vision, and prescription drug coveragecheck_circleCompany provided basic life, accidental death & dismemberment insurancecheck_circleShort-term and long-term disability insurancecheck_circleTuition reimbursement and student loan assistanceGenerous 401(k) match
Otsuka America, Inc. logo
Company

Otsuka America, Inc.

Industry

Healthcare & Nursing

View company profilearrow_forwardlanguageWebsite
Quick Overview

Experience

8+ yrs (Lead)

Education

Bachelor's degree in life sciences, engineering, or related field required

Job Type

Full-Time

Skills Required

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check_circle
check_circleFlexible time off, paid holidays, and paid leave programs
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