Otsuka Pharmaceutical Co.
Associate Director, Global Product Quality
Otsuka Pharmaceutical Co., Myrtle Point, Oregon, United States, 97458
Employer Industry: Pharmaceutical Manufacturing
Why consider this job opportunity:
Salary up to $219,650.00, 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
What to Expect (Job Responsibilities):
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
What is Required (Qualifications):
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
How to Stand Out (Preferred Qualifications):
Advanced degree in Chemistry or other Physical Sciences
Experience with Pre Approval Inspections for NDAs
TrackWise experience
Demonstrated success in leading cross‑functional teams
Experience in driving continuous improvement projects
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Why consider this job opportunity:
Salary up to $219,650.00, 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
What to Expect (Job Responsibilities):
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
What is Required (Qualifications):
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
How to Stand Out (Preferred Qualifications):
Advanced degree in Chemistry or other Physical Sciences
Experience with Pre Approval Inspections for NDAs
TrackWise experience
Demonstrated success in leading cross‑functional teams
Experience in driving continuous improvement projects
#J-18808-Ljbffr