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Otsuka Pharmaceutical Companies (U.S.) · 2 days ago

Associate Director, Global Quality Operations

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$147K/yr - $220K/yr

8+ years exp

Otsuka Pharmaceutical Companies (U.S.) is looking for an Associate Director in Global Quality Operations to lead initiatives that enhance operational excellence and optimize global quality system processes. This role is crucial in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

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

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

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

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

Qualification

Pharmaceutical quality operationsGxP regulationsOperational excellenceProcess improvement methodologiesGlobal quality systems platformsDigital transformationData analyticsLeadershipCommunicationProject managementCollaboration

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

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

Paid leave programs

Other company provided benefits

Company

Otsuka Pharmaceutical Companies (U.S.)

Glassdoor4.1

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.

Founded in 1989

Rockville, Maryland, USA

1001-5000 employees

https://www.otsuka-us.com

H1B Sponsorship

Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (6)

2023 (11)

2022 (5)

2021 (9)

2020 (13)