Senior Director of GMP Quality Assurance - Remote

Overview

The Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio, ensuring compliance with cGMP standards and overseeing QA activities.

In Short

• Lead the global GMP QA strategy for the company’s portfolio.
• Provide leadership and mentorship to the quality system team.
• Collaborate with contract manufacturing and testing partners.
• Oversee batch record reviews for compliance.
• Manage QA release of clinical trial materials.
• Execute QA Audit Plans and lead internal and external audits.
• Collaborate with cross-functional teams on quality objectives.
• Stay updated on regulations and industry trends.
• Explore AI technologies for quality assurance improvements.
• Foster a culture of quality excellence across the organization.

Requirements

• Bachelor’s or Master’s degree in Life Sciences or related field.
• 15+ years of experience in quality assurance in the pharmaceutical industry.
• Strong understanding of cGMP regulations and quality systems.
• Experience with batch record reviews and QA release processes.
• Proven track record in managing Quality Agreements.
• Experience in developing GMP audit programs.
• Strong leadership and communication skills.
• Ability to analyze data and implement quality improvements.
• Proficiency in quality management tools and methodologies.
• Excellent problem-solving skills and attention to detail.

Benefits

• Competitive salary range based on location.
• Equity options.
• Generous perks and comprehensive benefits.
• Hybrid work flexibility.