Associate Director, Global Product Quality - Biologics

Employer Industry: Pharmaceutical Development

• Salary up to $, plus incentive opportunities
• Comprehensive benefits package including medical, dental, vision, and prescription drug coverage
• Generous 401(k) match and tuition reimbursement
• Flexible time off and paid leave programs
• Opportunity for career advancement and growth within a global organization
• Engage in impactful work that ensures the quality of biologics products for patients

• Direct quality oversight of GMP contract manufacturers for clinical and commercial products
• Develop comprehensive quality strategies for biologic development programs
• Establish and maintain effective Quality Systems for batch record review and release processes
• Interface with Contract Manufacturers and other departments to drive quality improvements
• 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 with batch review and release activities
• Proven experience with biologics GMP manufacturing processes
• Excellent interpersonal and communication skills

• Advanced degree in Biology or other Physical Sciences
• Experience with quality oversight of controlled substances

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