Director of Quality Management Systems - Remote

Overview

The Director, Quality Management Systems plays a pivotal role in ensuring quality, safety, and efficacy of pharmaceutical products through the establishment and continuous improvement of an effective, compliant and ‘fit for purpose’ quality management system (QMS) ensuring Formation Bio is in a phase appropriate, inspection ready state.

In Short

• Develop, implement, and maintain the pharmaceutical quality management system (QMS).
• Establish and maintain quality assurance procedures and documentation.
• Lead internal and external audits for compliance assessment.
• Collaborate with cross-functional teams on quality objectives.
• Develop quality metrics and KPIs for QMS performance.
• Ensure timely investigation of deviations and complaints.
• Stay updated on regulatory changes and implement necessary updates.
• Provide leadership and mentorship to the quality system team.
• Serve as a subject matter expert during inspections and audits.

Requirements

• Strategic thinker with expertise in pharmaceutical quality systems.
• Bachelor’s degree in pharmacy or related field; advanced degree preferred.
• 12+ years of experience in quality assurance in the pharmaceutical industry.
• In-depth knowledge of FDA regulations and ICH guidelines.
• Experience in managing quality management systems.
• Strong leadership and communication skills.
• Experience leading regulatory inspections and audits.
• Ability to analyze data and implement quality improvements.
• Proficiency in quality management tools and methodologies.
• Strong organizational skills and attention to detail.

Benefits

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