Vice President, Product Quality
The mission of Centessa Pharmaceuticals plc (Nasdaq: CNTA) is to deliver consequential new medicines to patients. The Centessa family includes ten wholly owned, highly specialized companies, with drug discovery and development programs in diverse therapeutic areas. The company’s organizational structure and approach combine the agility and sense of urgency typical of start-up companies with the scale and diversification typical of larger R&D organizations.
Reporting into the Chief Quality Officer, the Vice President, Product Quality role is a key, strategic leadership position within the Centessa Pharmaceuticals organization and will play a critical role in the formulation and implementation of the next evolution of Quality within Centessa.
This person will be tasked with driving progressive, risk-based quality and patient safety approaches and programs for early and late-stage product development candidates including quality aspects of analytical stability, and control strategies. More specifically, the Vice President has responsibility for working with the CQO, CTO, and the R&D subsidiary network to establish a strategic, scalable and sustainable operating model for R&D, and eventually, Commercial Quality.
- Work closely with the CQO to define and establish an integrated and connected Product Quality framework for all aspects of product development from discovery research to pipeline commercialization including product quality CMC strategy and GxP quality assurance.
- Lead Quality’s risk management program
- Work with senior management within each subsidiary company to develop and implement Centessa's enterprise-wide Product Quality standards, practices and SOPs.
- Lead a team of quality professionals; direct supervision of Quality employees, including objective setting, performance management, coaching, training/mentoring, development and recruiting.
- Define, implement and maintain product quality risk assessments, critical attributes and control strategies in alignment with regulatory requirements and deep scientific understanding of the product and patient population
- In partnership with the Senior Leadership, set strategy and assure appropriate management oversight of Product Quality performance.
- Participate in “Inspection Readiness” and ensure product quality framework meets regulatory expectations for all US and global inspections by any regulatory authority
- Interface with regulators on product quality topics, as required
- Recommend, monitor, and engage in product impact assessments and corrective actions for all identified deviations from GxPs - GMPs, GCPs, GLPs, GVPs, SOPs
- Minimum 10 years of Quality experience across multiple GxPs within a high-performance drug development environment, ideally with a broad emphasis across GMP, GCP, GVP and GLP
- Will bring broad and deep regulatory, scientific, and technical knowledge and will be fluent in the fundamental principles and practices of drug development and possess the requisite understanding and track record of demonstrating the benefits of quality compliance to research and development, clinical and commercial manufacturing, clinical trial contracting/recruiting, medical affairs, medical safety, regulatory affairs and senior management with a functional grounding in both the US and international regulations and guidance is required, along with the experience of previously building out a global and progressive Product Quality team.
- Prior leadership of a Quality group; direct supervision of Quality employees, including objective setting, performance management, coaching, training, development and recruiting.
- Successful record of creating, building, designing and developing Quality organizations; proven ability to structure an organization and to lead the empowerment of the entire team to maximize results.
- Proven ability to develop and advance progressive product quality operational models, systems, framework in a fit-for-purpose manner enabling effectiveness, sustainability, flexibility, and adaptability in a dynamic and evolving business model.
- Prior experience in the successful preparation and conduct of a regulatory inspection by any US or international regulatory authority and experience interacting face-to-face with regulators.
- Current knowledge of industry trends and best practices for progressive product quality and CMC strategies within a regulated environment.
POSITION: Full-Time, Exempt, Flexibility for Remote Work
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.