VP, Quality Assurance

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

We are seeking a highly accomplished, strategic Vice President of Quality Assurance. In this pivotal role, you will establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development capabilities. This position reports to the Chief Development Officer. As the VP of Quality Assurance, you will establish and manage the organization to ensure compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).

The primary responsibilities are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development activities at Formation Bio. As a tech enabled development organization, there is a substantial component of oversight for the computer systems validation. The implementation of the QA strategy will involve leadership and guidance to the organization, along with building a team and maintaining up to date knowledge through internal and external partnership.

• 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.

• BS/BA in biology or related Life Sciences discipline, or equivalent experienced.
• Minimum of 20 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development. Specific experience with oversight of CSV is preferred.
• 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…