Otsuka
Associate Director, Global Product Quality - Biologics
Otsuka, Myrtle Point, Oregon, United States, 97458
Employer Industry
Biopharmaceuticals
Why consider this job opportunity
Salary up to $219,650.00
Comprehensive medical, dental, vision, and prescription drug coverage
Generous 401(k) match and flexible time off
Opportunities for continuous improvement and professional development
Collaborative work environment with cross‑functional teams
Potential for domestic and occasional international travel
What to Expect (Job Responsibilities)
Direct quality oversight of GMP contract manufacturers for clinical and commercial products
Develop comprehensive quality strategies addressing unique manufacturing challenges
Establish and maintain effective Quality Systems for managing batch record review and release
Transform biologic manufacturing quality challenges through innovative approaches
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 experience with biologics GMP manufacturing processes
Excellent interpersonal and communication skills
How to Stand Out (Preferred Qualifications)
Advanced degree in Biology or other Physical Sciences
Experience with quality oversight of controlled substances
We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top‑tier employer.
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Why consider this job opportunity
Salary up to $219,650.00
Comprehensive medical, dental, vision, and prescription drug coverage
Generous 401(k) match and flexible time off
Opportunities for continuous improvement and professional development
Collaborative work environment with cross‑functional teams
Potential for domestic and occasional international travel
What to Expect (Job Responsibilities)
Direct quality oversight of GMP contract manufacturers for clinical and commercial products
Develop comprehensive quality strategies addressing unique manufacturing challenges
Establish and maintain effective Quality Systems for managing batch record review and release
Transform biologic manufacturing quality challenges through innovative approaches
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 experience with biologics GMP manufacturing processes
Excellent interpersonal and communication skills
How to Stand Out (Preferred Qualifications)
Advanced degree in Biology or other Physical Sciences
Experience with quality oversight of controlled substances
We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top‑tier employer.
#J-18808-Ljbffr