Director, GMP Quality Assurance

We are seeking a dynamic and results-driven Director of GMP Quality Assurance to join our team. The ideal candidate will have a minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in auditing and the manufacture of monoclonal antibodies or biologics.

Requirements

• A bachelor’s degree in a relevant scientific discipline or equivalent
• A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry
• Direct experience in auditing and the manufacture of monoclonal antibodies or biologics
• Experience with CDMO oversight, including partnering and aligning on quality issues
• Experience with Quality Management System Regulations
• In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with analytical instrumentation, methods, validation, and investigations including stability program management
• Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
• Strong communication (oral and written), and effective interpersonal skills with the ability to influence and drive change
• Excellent problem-solving and critical thinking abilities
• Flexible and creative to meet the needs and challenges of a growing, dynamic company
• Focus on fostering a culture of collaboration and teamwork
• Ability to manage multiple projects with fast timelines and changing priorities

Benefits

• Market competitive compensation and benefits package
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave