Formation Bio is hiring a
Director Quality Systems QA in United States

Summary

The Director, Quality Systems position at Formation Bio is responsible for developing, implementing, and maintaining the QMS to ensure compliance with regulatory requirements. The role involves leading internal and external audits, collaborating with cross-functional teams, and providing leadership to the quality system team.

Requirements

• Bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, or a related scientific discipline. Advanced degree (e.g., Master's or PhD) is preferred
• Extensive experience (+12 years) in quality assurance roles within the pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes

Responsibilities

• Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements
• Establish and maintain quality assurance procedures, processes, and documentation to ensure the consistent production of safe, effective, and high-quality pharmaceutical products
• Lead internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions (CAPAs) as needed
• Collaborate with cross-functional teams (e.g., Engineering, Tech, R&D, Manufacturing, Regulatory Affairs) to ensure alignment on quality objectives, initiatives, and priorities
• Develop and implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement
• In collaboration with GXP Quality Leads, ensure the timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy
• Stay abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the QMS

Benefits

• Competitive compensation relative to the New York City market
• Equity
• Generous perks
• Location flexibility
• Comprehensive benefits