Associate Director, Global Quality Operations

Employer Industry: Pharmaceutical Quality Operations

• Salary range up to $219,650, with an incentive opportunity
• 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 within a global organization
• Engage in impactful work that aligns quality operations with strategic business goals

• Lead continuous improvement initiatives to enhance efficiency and compliance within global quality operations
• Develop and maintain a quality risk management framework in alignment with ICH Q9 principles
• Oversee the design and implementation of global quality system processes, ensuring harmonization across sites
• Ensure compliance with global regulatory requirements and support internal audits and regulatory inspections
• Collaborate with cross-functional teams to align quality operations with organizational objectives

• Bachelor’s degree in life sciences, engineering, or a related field; advanced degree preferred
• 8+ years of experience in pharmaceutical quality operations, including exposure to both small molecules and biologics
• Strong knowledge of GxP regulations, quality systems, and risk management principles
• Proven experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma)
• Excellent communication, leadership, and project management skills

• Experience with global quality systems platforms (e.g., Veeva, Track Wise)
• Familiarity with digital transformation and data analytics in quality operations
• Prior involvement in regulatory inspections and audit readiness

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