Senior Director, GMP QA

Summary

Join Formation Bio, a tech and AI-driven pharma company, as the Sr. Director, GMP Quality Assurance. Lead the global GMP QA strategy and execution for the company's portfolio. Serve as the QA subject matter expert, supporting CMC development activities and ensuring compliance with cGMP standards. Oversee QA activities at CDMOs, perform critical documentation reviews, and develop SOPs. Explore opportunities to integrate AI technologies to improve efficiency and quality. Mentor the quality system team and collaborate with cross-functional teams. Stay updated on regulatory changes and industry trends.

Requirements

• Strategic and creative thinker, independent strong leader, and subject matter expert in cGMPS and a passion for driving a quality mindset across the organization
• Bachelor’s or Master’s degree in Life Sciences, Engineering or a related scientific discipline
• Extensive experience (+15 years) in quality assurance roles within the pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes
• In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines
• Demonstrated experience with batch record reviews and QA release of clinical trial materials
• Proven track record of overseeing quality activities at CDMOs and managing Quality Agreements
• Experience developing and managing GMP audit programs and ensuring timely CAPA closure
• Strong leadership and communication skills, with the ability to effectively collaborate, influence and educate stakeholders at all levels of the organization
• Experience leading regulatory inspections (e.g., FDA inspections, MHRA inspections, EMA inspections, etc. ) and customer audits, with a track record of successful outcomes
• Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance
• Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPA effectively
• Proficiency in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems
• Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment. Experience working independently

Responsibilities

• Develop, implement, and oversee the global GMP QA strategy for the company's portfolio
• Provide leadership, mentorship, and coaching to the quality system team, fostering a culture of quality excellence, accountability, and continuous learning
• Serve as the QA subject matter expert for all CMC-related quality activities and collaborate with the CMC team on the following: specification development, investigational product manufacturing/packaging and release, stability program design and execution, change management processes, vendor selection and internal and external GMP related audits
• Collaborate with and provide Quality oversight to contract manufacturing, packaging/labeling, and testing partners. Support the development and maintenance of Quality Agreements with external partners
• Monitor CDMO and vendor performance and ensure timely resolution of quality issues
• Oversee and perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements
• Manage QA release of clinical trial materials to ensure availability for trials
• Establish and maintain ‘fit for purpose’ GMP related quality assurance procedures processes, and documentation to ensure the consistent production of safe, effective, and high-quality pharmaceutical products. Cultivate support and commitment across other FB departments in support of the Quality System and facilitate development of controlled documents outside of QA
• Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance with regulatory requirements, track audit report responses, identify areas for improvement, and implement corrective and preventive actions (CAPA as needed
• Collaborate with cross-functional teams (e.g., CMC, Regulatory Affairs, Clinical Operations) to ensure alignment on quality objectives, initiatives, and priorities
• Stay abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the QMS

Preferred Qualifications

• Additional experience in GLP and/or GCP regulated environments preferred
• Small virtual company experience preferred
• Veeva experience preferred
• Curious about AI technologies and interested in exploring ways of applying them to the Quality function

Benefits

• Equity
• Generous perks
• Hybrid flexibility
• Comprehensive benefits