Sr Mgr/Associate Director, GMP Quality Assurance

Overview

Role involves managing GMP Quality Assurance activities and ensuring compliance with regulatory standards.

Ideal candidate should have extensive experience in GMP/CMC QA and strong leadership skills.

Locations

• United States, Massachusetts, Boston
• United States, California, San Diego

Requirements

• BS/MS in scientific discipline
• 8+ years experience for Sr. Manager
• 10+ years experience for Associate Director
• GMP/CMC QA experience required
• Knowledge of US, EU, ICH regulations
• Proficient in quality software
• Strong communication and leadership skills
• Ability to travel internationally

Responsibilities

• Oversee GMP activities
• Ensure quality oversight of vendors
• Review and approve GMP documentation
• Generate quality metrics
• Support Health Authority inspections
• Collaborate with cross-functional teams
• Evaluate GMP activities for improvement
• Provide QA leadership

Benefits

• Career advancement opportunities
• Competitive compensation package
• Bonus
• 401K with employer contributions
• Generous stock options
• 20 days PTO
• Paid parental leave
• Home office setup