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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 Pharmaceutical Co.
Full Time
position Listed on 2025-12-21
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Job Description & How to Apply Below
Employer Industry: Pharmaceutical Manufacturing
Why consider this job opportunity:- Salary up to $, plus incentive opportunities
- Comprehensive benefits package including medical, dental, vision, and prescription drug coverage
- Generous 401(k) match and tuition reimbursement options
- Flexible time off and paid leave programs
- Opportunity for career advancement and involvement in continuous improvement projects
- Collaborative work environment with cross‑functional teams
- Direct quality oversight of GMP contract manufacturers of controlled substances for clinical and commercial products
- Collaborate with cross‑functional teams to ensure compliance with controlled substance regulations
- Manage and improve corporate controlled substance oversight standards and inspection readiness
- Establish and maintain Quality Systems for batch record review and release processes
- Conduct audits of Contract Manufacturers/Laboratories 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 with batch review and release activities
- Proven expertise in conducting root cause investigations and implementing CAPA
- Excellent interpersonal and communication skills
- Advanced degree in Chemistry or other Physical Sciences
- Experience with Pre Approval Inspections for NDAs
- Track Wise experience
- Demonstrated success in leading cross‑functional teams
- Experience in driving continuous improvement projects
Position Requirements
10+ Years
work experience
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