Director, Quality Systems, QA

March 16

Formation Bio

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Bringing new treatments to patients faster and more efficiently.

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Description

• 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. • 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.

Requirements

• 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.

Benefits

• Competitive compensation • Competitive relative to the New York City market • Salary range for this role is $190,000 - $240,000 • Equity • Generous perks • Location flexibility • Comprehensive benefits