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  1. Home
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  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_onCarlos Gilbert Elementary School, 300, Griffin Street, Santa Fe, Santa Fe County, New Mexico, 87501, 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 fully aligned with our strategic business goals. You will lead continuous improvement initiatives that not only enhance efficiency and effectiveness but also foster a culture of accountability and patient-centricity 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 regions, 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 rigorous adherence to global regulatory requirements like FDA, EMA, and PMDA standards.

Our Culture and Values

At Otsuka, we are committed to fostering an environment of respectful collaboration and empowered development. We value diverse partnerships and seek individuals who maintain an ongoing focus on the needs of our customers and patients. As a leader in this role, you will be expected to communicate with logic, clarity, and respect, influencing stakeholders at all levels to achieve the best results. We believe that strategic thinking and problem-solving are essential for making decisions that consider the long-term impact on our business, employees, and the patients we serve.

Hiring Process and Application

Qualified candidates are encouraged to apply directly through the official Otsuka Career website. Please note that this position will be posted for a minimum of 5 business days. We review applications on a rolling basis and look forward to learning about your experience in pharmaceutical quality operations.

Equal Opportunity and Safety

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, sexual orientation, age, disability, religion, national origin, veteran status, or marital status. Reasonable accommodations are available for individuals with disabilities or disabled veterans who may need assistance during the application process.

Important Security Notice: Otsuka takes the security of your personal information seriously. We will never ask for financial information, payment, or credit card details during the job application process, nor will we ask you to download third-party applications to communicate about a legitimate opportunity. Please be cautious of fraudulent offers and only communicate through official Otsuka channels.

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Work location

Work model: On-site

location_on

Carlos Gilbert Elementary School, 300, Griffin Street, Santa Fe, Santa Fe County, New Mexico, 87501, United States

Santa Fe, New Mexico

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_circleAnalyze KPIs and dashboards to identify trends, root causes, and opportunities for improvement
  • check_circleCollaborate with cross-functional teams to streamline end-to-end workflows and optimize operations

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 assistancecheck_circleGenerous 401(k) matchcheck_circleFlexible time off, paid holidays, and paid leave programs
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

Ich Q9Deviation ManagementCapaChange ControlDocument ManagementGXP
Not Disclosed
arrow_forward
Recrutus

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