Senior Director, GMP QA

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. 

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others. 

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

The Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting as the QA subject matter expert, this role supports CMC development activities, including specification development, manufacturing, product release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs, performs critical documentation reviews, and develops/evolves ‘fit-for-purpose’ SOPs aligned wit the QMS. Additionally, the role explores opportunities to integrate artificial intelligence

(AI) technologies to improve efficiency, compliance, and overall quality assuran practices. 

Responsibilities

• Develop, implement, and oversee the global GMP QA strategy for the company’ 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. 

About You

• Strategic and creative thinker, independent strong leader, and subject matter expert in cGMPS and a passion for driving a quality mindset across the organization. 
• Curious about AI technologies and interested in exploring ways of applying them to the Quality function. 
• Bachelor’s or Master’s degree in Life Sciences, Engineering or a related scientif discipline. 
• Extensive experience (+15 years) in quality assurance roles within t pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes. Additional experience in GLP and/or GCP regulated environments preferred. Small virtual company experience preferred. 
• 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. Veev experience preferred. 
• Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment. Experience working independently. 

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate.

Compensation:

The target salary range for this role is: $235,000 - $370,000.

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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