Otsuka Pharmaceutical Companies (U.S.) · 19 hours ago
Associate Director, Global Product Quality-Controlled Substances
United States
Full-time
Remote
Lead/Staff, Director/Executive
$150K/yr - $224K/yr
10+ years expOtsuka Pharmaceutical Companies (U.S.) is seeking an Associate Director for Global Product Quality in Controlled Substances. This role is responsible for directing quality oversight of clinical and commercial controlled substances, ensuring compliance with regulatory expectations and quality standards while collaborating across departments to maintain effective quality systems.
Health CareMedical
Responsibilities
Responsible for directing quality oversight of GMP contract manufacturers of controlled substances for Otsuka clinical and commercial products
Support cross-functional teams to ensure alignment and compliance with controlled substance regulations
Provides guidance and expertise to sites and business units to assess the facilities, and/or business operations, compliance of DEA regulations and site procedures
Managing, updating and improvements of corporate controlled substance oversight standards. Provide oversight to ensure inspections readiness
Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product) for controlled substances
Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance
Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted aboveImproves supplier quality performance for batch record review and release process for
OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products
Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc
Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP
Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable controlled substance regulatory requirements
Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met
Qualification
Required
Bachelor's degree in Chemistry, Biology or other Physical Sciences
Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial and development controlled substances
Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects
Expertise in conducting root cause investigations and driving CAPA implementation
Ability to supervise multiple direct reports and projects in a fast-paced environment
Demonstrated success in working on and leading cross functional teams
Experience with Pre Approval Inspections for NDAs
Experience in driving continuous improvement projects
TrackWise Experience
Excellent interpersonal and communication skills
Position requires approximately 20% domestic travel; Occasional international travel may also be expected
Preferred
Advanced degree in Chemistry or other Physical Sciences
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.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
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
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2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
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