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Otsuka Pharmaceutical Companies (U.S.) · 1 day ago

Manager, Global Quality Management - Clinical Audit

United States

Full-time

Remote

Mid Level

$117K/yr - $175K/yr

3+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Global Quality Audit Manager responsible for planning, executing, and reporting on global audits to ensure Good Clinical Practice compliance. The role involves collaborating with cross-functional stakeholders to identify risks, drive continuous improvement, and maintain the integrity of clinical trial data.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Audit Execution: Plan, conduct, and report GCP audits of CROs, clinical laboratories, and investigator sites globally, ensuring compliance with ICH-GCP, local regulations, and company policies. Provide oversight to contract and consultant resources in audit conduct and reporting

Risk-Based Audit Planning: Support the development and maintenance of a global audit schedule based on risk assessments, regulatory requirements, and business priorities

Audit Reporting & Follow-Up: Document audit findings, issue formal reports, and ensure timely follow-up and closure of corrective and preventive actions (CAPAs)

Stakeholder Engagement: Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other functions to ensure alignment on quality expectations and audit outcomes

Continuous Improvement: Identify trends and systemic issues from audit findings and contribute to the development of global quality improvement initiatives

Training & Guidance: Provide GCP compliance training and guidance to internal teams and external partners as needed

Metrics & Reporting: Maintain audit metrics and contribute to management reporting on audit outcomes, trends, and compliance risks

Qualification

GCP auditingICH-GCP knowledgeClinical quality assuranceAudit management systemsMicrosoft Office proficiencyAnalytical skillsRisk assessmentStakeholder engagementOrganizational skillsCommunication skills

Required

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field; advanced degree preferred

3 -5 years of experience in clinical quality assurance or GCP auditing within the pharmaceutical, biotech, or CRO industry

In-depth knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements related to clinical research

Experience auditing CROs, investigator sites, and clinical laboratories

Strong analytical, organizational, and communication skills

Ability to work independently and manage multiple audits across global regions

Proficiency in audit management systems and Microsoft Office tools

Willingness to travel internationally up to 20%

Preferred

Familiarity with TrackWise or similar quality management systems

Experience working with CROs or external vendors

Exposure to FDA or other health authority inspections

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)