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Associate Director, Global Product Quality
Job in
Coos Bay, Coos County, Oregon, 97458, USA
Listed on 2025-12-21
Listing for:
Otsuka
Full Time
position Listed on 2025-12-21
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
Employer Industry
Pharmaceutical Manufacturing
Why consider this job opportunity- Salary up to $, plus incentive opportunity
- Comprehensive medical, dental, vision, and prescription drug coverage
- Generous 401(k) match and tuition reimbursement available
- Flexible time off and paid holidays
- Opportunity for career advancement and growth within the organization
- Chance to make a significant impact on product quality and compliance in the pharmaceutical industry
- Direct quality oversight of GMP contract manufacturers of controlled substances for clinical and commercial products
- Support cross-functional teams to ensure compliance with controlled substance regulations
- Manage and improve corporate controlled substance oversight standards and ensure inspection readiness
- Establish and maintain Quality Systems for batch record review and release processes
- Conduct audits of contract manufacturers to ensure compliance with regulatory requirements
- Bachelor’s degree in Chemistry, Biology, or other Physical Sciences
- Ten years of experience in pharmaceutical manufacturing, QA, or QC assurance roles
- Seven years of product quality experience in batch review and release activities
- Expertise in conducting root cause investigations and implementing CAPA
- Ability to supervise multiple projects in a fast-paced environment
- Advanced degree in Chemistry or other Physical Sciences
- Experience with Pre Approval Inspections for NDAs
- Familiarity with Track Wise software
- Proven success in leading cross-functional teams
- Experience in driving continuous improvement projects
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Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
Position Requirements
10+ Years
work experience
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