Formation Bio · 12 hours ago
Vice President, Quality Assurance
New York, NY
Full-time
Hybrid
Director/Executive
$335K/yr - $420K/yr
20+ years expFormation Bio is a tech and AI driven pharma company focused on efficient drug development. The Vice President of Quality Assurance will establish and manage the quality assurance program to ensure compliance with regulatory standards and support the company's drug development capabilities.
Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical
Responsibilities
Oversee GXP, Data Integrity, and CSV activities across various entities, investigator sites, research organizations, clinical and nonclinical studies, PV vendors, and CDMOs
Maintain efficient systems and processes that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards
Provide leadership and direction to the quality assurance team, ensuring that all quality activities are carried out efficiently and effectively
Ensure the appropriate identification, evaluation, and management of risks associated with product quality
Build strong relationships with regulatory agencies and other stakeholders, representing the company's interests and ensuring compliance with all relevant regulations
Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle
Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions
Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation
Foster a culture of continuous improvement and development within the quality assurance team, ensuring that all team members have the support and resources they need to succeed
Creating and implementing risk-based quality strategies that identify and address potential quality risks
Managing quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues
Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections
Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and quality metrics.standard operating procedures (SOPs) pertaining to GXP CSV and PV activities. Leading quality investigations and approving plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations
Staying updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV/CSV regulations and guidance
Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities
Qualification
Required
BS/BA in biology or related Life Sciences discipline, or equivalent experience
Minimum of 20 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development
Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines
Expertise in Quality Management Systems (QMS)
Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation
Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members
Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient
Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff
Demonstrated ability to lead and motivate cross-functional teams
Willingness and desire to 'roll up your sleeves' and perform activities and responsibilities to support the team
Preferred
Specific experience with oversight of CSV is preferred
Benefits
Equity
Comprehensive benefits
Generous perks
Hybrid flexibility
Company
Formation Bio
Formation Bio is a drug development company that strives to provide treatments to patients faster by reimagining clinical trials.
51-200 employees
H1B Sponsorship
Formation Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
Funding
Current Stage
Late StageTotal Funding
$528MKey Investors
Andreessen Horowitz
2024-06-26Series D· $372M
2021-09-30Series C· $156M
2018-10-15Series Unknown
Leadership Team
Benjamine Liu
CEO and Co-Founder
Linhao Zhang
Co-Founder and COO
Recent News
Spark Capital
2026-01-07
BioWorld Financial Watch
2025-12-19
2025-12-16
Company data provided by crunchbase