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Director of Quality Management Systems - Remote

Posted 6 weeks ago
All others
Full Time
USA
$190,000 - $270,000/year

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.
Formation Bio logo

Formation Bio

Formation Bio is a technology and AI-driven pharmaceutical company that aims to revolutionize drug development by creating more efficient processes for clinical trials. Founded in 2016 as TrialSpark Inc., the company addresses the bottleneck in drug development caused by high costs and lengthy timelines. Formation Bio partners with pharmaceutical companies, research organizations, and biotechs to advance drug programs beyond clinical proof of concept, ultimately facilitating the delivery of new medicines to patients. Backed by prominent investors from both the pharmaceutical and tech industries, Formation Bio is committed to leveraging innovative quantitative approaches and technology to enhance all aspects of drug development.

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