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Otsuka Pharmaceutical Companies (U.S.) · 14 hours ago

Manager, Global Quality Management - Princeton, NJ or Rockville, MD

Rockville, MD

Full-time

Onsite

Entry, Mid Level

$108K/yr - $161K/yr

2+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager for their Global Quality Management team. The role focuses on supporting GxP audit coordination, inspection readiness, and various quality assurance activities to ensure compliance and continuous improvement within the organization.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Coordinate, support, and manage GxP Audit activities

Organize audit preparation meetings

Track Audit scheduling and keep Master Audit Schedule tracker up-to-date

Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees

Assist the audit programme with planning, communicating, documenting, and executing the GxP audit strategy

Support the Global Quality Management team in risk assessment activities

Support the preparation and review of Audit Reports

Support the continuous improvement and enhancement of the Quality System (e.g., Trackwise, ACE, etc.)

Collaborate with the respective Functional Areas representatives as required for audits

Foster a continuous improvement mentality within Otsuka

Support the establishment and maintenance of the required Audit/Inspection Documentation

Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution

Support the preparation for inspections

Support the Global Quality Management teams with the responses to Regulatory Authorities

Support the review and assessment of corrective and preventive actions (CAPA)

Manage ACE Chat, Scribe Notes and other assigned activities

Qualification

GxP audit coordinationCAPA managementRegulatory inspectionsQuality System knowledgeMS Office proficiencyAnalytical thinkingCommunication skillsProblem solvingTeam collaboration

Required

BS degree in the sciences

2 or more years in multi-national biopharmaceutical industry that includes performing GxP audits, or clinical monitoring or inspection readiness activities

Experience in CAPA management

Exposure to regulatory inspections

Knowledge of regulations and guidance regarding clinical development

Understanding of Good Clinical Practice processes

Understanding of audits and CAPA management

Ability to work independently and as part of a quality team supporting the lifecycle of audits

Excellent communication skills (written and oral) in English

Problem solving and resolution skills

Analytical and creative thinking

Understanding of being risk based focused and prioritizing work based on Risk Management methodologies

Preferred

Well versed with MS Office (advance users in Excel & PowerPoint preferred). Knowledge of TrackWise, ACE, Veeva desirable

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)