Director, Quality Management Systems

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 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. This role is responsible for overseeing all aspects of the quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry standards, and best practices in pharmaceutical manufacturing and defending it during health authority audits.

Responsibilities

• Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA), industry standards (e.g., cGMP), and company policies.
• 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.
• Provide leadership, mentorship, and coaching to the quality system team, fostering a culture of quality excellence, accountability, and continuous learning.
• Serve as a subject matter expert on quality assurance matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements.

About You

• Strategic and creative thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to design and implement a ‘fit for purpose’ Quality Management System 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 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. 
• In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines.
• Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control, training management, change control, corrective action preventative action, and deviation management processes.
• 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 (CAPAs) 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.

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: $190,000 - $300,000.

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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