The Head of Clinical Quality - Biotechnology will lead the entire Quality organization across the business. This pertains to provision quality oversight, hiring training key staff, and serving as the Quality representative to senior leadership and key stakeholders.
Our latest client is an innovative biotechnology start-up based in the Worcester area. This company is in its pre-clinical trial stages with a successful IND completion to the FDA and anticipates a launch of clinical trials by next year.
Due to strong initial findings in research and backing of key stakeholders, this company has received significant funding for its operations and future commercialization.
- 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
- Great additional compensation package including bonuses, shares, and other incentives
- Breakthrough biotechnology product with strong initial findings in research
- Key leadership position with decisions to influence internal and external stakeholders
- Strong benefits package
- Strong innovative culture and atmosphere
- Significant long-term funding from paret company