Reporting to the Chief Technology Officer, this position works internally across the organization to provide the strategic vision, results-oriented leadership and creativity required to build and maintain a world-class organization and establish a robust and efficient Quality System. This pertains to provision of quality oversight, hiring and training staff, and leading Quality to senior management, key stakeholders, and regulatory authorities.
Our latest client is an innovative biotechnology & biopharmaceutical start-up based in the Worcester area. This company focuses on the development of novel immunotherapies based on ground-breaking research, with an emphasis on a successful IND submission in 2018 and launch of clinical trials in 2019.
- Provide quality oversight for all GxP activities at the facility ensuring processes and practices are compliant with global Good Clinical (GCP), current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP).
- Recruit and develop staff to execute department functions; ensure effective utilization of resources through consistent performance management, and rewards and recognitions practices.
- Develop, maintain, and administer an efficient and effective risk-based Quality Management System in compliance with regulatory requirements and industry recognized best practices for biologic, cell therapy, and gene therapy commercial and clinical products.
- Establish key performance indicators in alignment with company and operational goals; maintain and report applicable department and Quality System metrics.
- Engage in proactive relationships with FDA and other U.S. and International regulatory authorities to facilitate the advancement of company objectives. When required, seek creative solutions and exert firm convictions in advancing company positions.
- PhD in life sciences and 8 - 10 years of experience in pharmaceuticals, biotechnology, gene/cell therapy, or medical devices OR Master's degree and 10 - 15 years; 7 years in management / leadership positions or an equivalent combination of education and experience.
- GCP experience is required - Minimum of 5 years Quality experience and a track record of managing successful clinical programs, quality management systems, and regulatory inspections.
- Strong collaboration and negotiation skills with the ability to influence the decisions of both internal and external stakeholders. The candidate must be able to work closely with peers in Manufacturing, Engineering, Facilities, and Regulatory to ensure company's objectives advance in a timely and cost-effective manner.
- Excellent base salary
- Breakthrough biopharma product with strong initial findings in research
- Life-saving products for alternative cancer treatment
- Diverse product pipeline with multiple lead candidates
- Key leadership position with decisions to influence internal and external stakeholders
- Shares options
- Strong benefits package
- Strong innovative culture and atmosphere
- Significant long-term funding