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Otsuka Pharmaceutical Companies (U.S.) · 3 days ago

Associate Director, Global Supplier Quality

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$147K/yr - $220K/yr

6+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking an Associate Director of Global Supplier Quality who will be responsible for the execution of supplier quality audit and monitoring across the global network of contract manufacturing organizations. This role focuses on ensuring the quality and reliability of pharmaceutical products by supporting the qualification and compliance of external manufacturing partners.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Support the qualification and ongoing monitoring of CMOs and critical suppliers

Execute supplier audits and ensure timely follow-up and resolution of findings

Maintain and update quality agreements in collaboration with internal stakeholders

Conduct risk assessments and support mitigation plans for supplier-related quality issues

Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH)

Prepare documentation and support internal and external audits and inspections

Maintain accurate records of supplier performance and audit outcomes

Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality is integrated into business processes

Serve as a point of contact for operational supplier quality issues and escalations

Track and report key performance indicators (KPIs) related to supplier quality

Provide regular updates to leadership on supplier performance and compliance status

May supervise or mentor junior quality staff or contractors

Support continuous improvement initiatives within the supplier quality function

Qualification

GMP regulationsSupplier auditsPharmaceutical qualitySupplier documentationRegulatory complianceMetrics reportingTeam supportCommunicationProblem-solving skillsCross-functional collaboration

Required

Bachelor's degree in a scientific or engineering discipline

6+ years of experience in pharmaceutical quality, with 2+ years in supplier or external manufacturing quality

Strong knowledge of GMP regulations for small molecules and/or biologics

Experience conducting audits and managing supplier documentation

Strong communication and problem-solving skills

Ability to travel internationally as needed

Preferred

Experience working with global CMOs

Familiarity with digital tools and systems for supplier management

Exposure to regulatory inspections and remediation activities

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)