Location: Watertown,MA, USA
About Affini-T Therapeutics
Affini-T Therapeutics is a clinical stage biotechnology company focused on building a best-in-class TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, we focus on enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment.
Job Summary
The Vice President, Quality Assurance is a critical leadership position responsible for the phase-appropriate conceptualization, implementation, and management of Affini-T Therapeutic's corporate quality systems to support the company's advancement of a broad pipeline of TCR cellular therapeutics for the treatment of solid tumors. The incumbent is tasked with the strategic development and operational management of the Company's quality assurance program; continually advancing an efficient, risk-based compliance framework, and staying on the leading edge of best practices and innovations in Quality Systems. This is a unique opportunity to shape and evolve the foundational quality systems at an early stage and rapidly growing biotechnology company with a highly people- and patient-centric, science-driven culture.
The ideal candidate will have extensive experience in multiple areas of Quality Assurance including oversight of all areas of GxP quality systems, including global partner and vendor relationships and audits, document control, training, teambuilding, budgeting, and strategic planning. The successful incumbent will join the company's Senior Leadership Team and will define and communicate the Quality vision and build a world-class Quality organization to deliver on this vision. The ideal candidate will be instrumental in shaping the technical, operational, and cultural evolution of the company and is someone who embraces the privilege of leadership with humility, grace, and an indomitable will to succeed.
Essential Duties and Responsibilities
The major tasks for this position are as follows:
* Responsible for leadership and oversight of Quality Assurance department - this includes defining and communicating the quality vision, and developing an organizational structure that is aligned with company growth.
* Build, lead and mentor a team of quality professionals to ensure quality and compliance throughout the organization. [Drive, promote and embed a culture of ethics, integrity and continuous improvement focused on delivering efficient outcomes.]
* Conceptualize, implement and manage corporate quality assurance and compliance systems fit for an early clinical stage biotechnology company - including a combination of authoring, reviewing, and approval of policies, SOPs, and business processes in collaboration with key stakeholders, as needed. Oversee continuous improvement of quality processes and procedures.
* Assure compliance with internal procedures and policies for applicable regulatory requirements (US, EU, ROW) and standards.
* Provide quality assurance oversight of GCP, GLP, and GMP operations for both internal and external production and use of regulated therapeutics products (ATMPs)
* Plan and host regulatory inspections, as well as external GxP audits.
* Maintain quality metrics to monitor and ensure that high levels of performance and quality are achieved by operational groups. Stay abreast of industry developments including forthcoming regulations, guidance etc to ensure quality metrics comply with best industry practices and train/mentor staff on key updates.
* Continuously communicate performance related targets to other members of senior leadership.
* Oversee strategy and the implementation of processes supporting investigations, risk assessments, implementation of GxP training, resolution of complaints and management of quality issues.
* Qualify and manage relationships with contract research and manufacturing organizations. This includes the assurance of compliance and quality of operations performed by these organizations, as well as regulatory inspection support.
* Responsible for building and maintaining a high-trust relationship between Quality and the rest of the organization, while ensuring Quality is viewed as an integral thought partner and creative problem solver across all levels and functional areas in the organization.
Desired and Required Qualifications
* Bachelor's or advanced degree (preferred) with a minimum of 15+ years of quality experience in a biotech/pharmaceutical environment, including 6-8+ years of prior experience leading a Quality function for development stage activities.
* Demonstrated experience establishing a quality organization and managing GMP/GCP/GLP staff.
* Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents
* Experienced in both conducting and hosting regulatory inspections for clinical and commercial products.
* Experienced in the implementation of phase-appropriate Quality Management Systems
* Experience in partnering with cell & gene therapy CDMOs and CROs in preferred.
* Successful history of contributing to NDA submissions for novel products
* Excellent interpersonal skills, clear and concise both verbal and written communications. Demonstrated ability inbuilding relationships with both internal and external partners
* Proven ability to create culture of accountability and ownership in a matrix environment; must be able to lead through influence.
* Track record of success delivering efficient, high-impact outcomes in a fast-paced growth environment. Strong organizational and time management skills, ability to effectively prioritize and manage complex projects.
* Excellent problem solving and decision-making skills.
* Desire to build and lead a high-performing team of colleagues at all levels, as the company continues to grow and advances its pipelines.