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

Manager, Global Product Quality - Controlled Substances

United States

Full-time

Remote

Senior Level

$105K/yr - $156K/yr

5+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager for Global Product Quality focused on Controlled Substances. This role is responsible for ensuring compliance with Good Manufacturing Practices and global regulatory requirements throughout the product lifecycle, particularly in relation to controlled substances.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers

Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls

Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required

Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances

Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives

Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products

Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities

Qualification

DEA regulations complianceGMP requirementsQuality systems managementFDA/ICH/USP knowledgeControlled substances experienceEQMS experienceCommunication skillsCollaboration skillsProject management skillsDetail oriented

Required

Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field

Minimum 5 – 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3–5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations

Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting

Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7

Strong understanding of GMP requirements and global regulatory expectations for controlled substances

Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment

Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances

Excellent communication, collaboration, and project management skills

Must be detail oriented and able to write and/or review Technical Documents

Ability to work effectively in a global, cross-functional, and matrixed environment

Preferred

Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar

Certification in DEA compliance, Quality Assurance, or Regulatory Affairs

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)