Senior Vice President of Quality Management
2 weeks ago
About Affini-T Therapeutics
Affini-T Therapeutics is an innovative biotech firm dedicated to targeting oncogenic driver mutations through a state-of-the-art TCR therapy platform. The company's unique methodology for identifying high-affinity TCRs specific to oncogenic driver mutations is employed to develop therapies for cancerous conditions.
Position Overview
The Senior Vice President of Quality Management plays a pivotal leadership role in the design, execution, and oversight of Affini-T Therapeutics' corporate quality frameworks. The primary aim is to facilitate the company's advancement of a diverse pipeline of TCR cellular therapies aimed at treating solid tumors. This position presents a remarkable opportunity to influence the foundational quality frameworks within a nascent and rapidly expanding biotech organization that prioritizes its people and patients.
Key Responsibilities
- Direct and manage the Quality Management department to articulate and disseminate the quality vision in alignment with organizational growth.
- Establish and guide a team of quality experts to ensure adherence to compliance across the organization.
- Develop and oversee corporate quality assurance and compliance frameworks suitable for an early clinical stage biotech enterprise.
- Guarantee compliance with internal protocols and regulatory standards.
- Supervise GCP, GLP, and GMP operations for both internal and external production activities.
- Plan and execute regulatory inspections and GxP audits.
- Track quality metrics to ensure optimal performance levels are achieved.
- Implement processes that support investigations, risk evaluations, GxP training, and resolution of quality challenges.
- Manage partnerships with research and manufacturing entities, ensuring compliance and quality standards are met.
- Foster a robust relationship between Quality and other departments within the organization.
Qualifications
- Bachelor's or advanced degree with a minimum of 15 years of quality experience in the biotech or pharmaceutical sector.
- Previous experience leading a quality function for development stage initiatives.
- Comprehensive understanding of regulatory standards and quality frameworks.
- Experience in conducting regulatory inspections and implementing Quality Management Systems.
- Collaboration experience with cell & gene therapy CDMOs and CROs is preferred.
- Proven track record of contributing to NDA submissions for new products.
- Exceptional interpersonal skills and ability to cultivate relationships both internally and externally.
- Demonstrated ability to foster a culture of accountability and ownership in a matrixed environment.
- Strong organizational, time management, problem-solving, and decision-making capabilities.
- Commitment to leading a high-performing team as the organization evolves and progresses.
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