About Formation Bio
At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%.
This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments.
Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.
About the Position
The Director, Quality Systems plays a pivotal role in ensuring quality, safety, and efficacy of pharmaceutical products through the establishment and continuous improvement of an effective and compliant quality management system (QMS) ensuring Formation Bio is in an 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 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.
- 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.
- Proven track record of building and managing a high performing team of professionals
- 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.
We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $190,000 - $250,000.
On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.
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.
