Head of Quality Assurance

About the Company

Pioneering contract research & development company

Industry
Research

Type
Privately Held

About the Role

The Company is in search of a Head of Quality Assurance with a focus on gene therapy. The successful candidate will be tasked with developing and implementing a comprehensive quality assurance strategy that aligns with business objectives and regulatory standards. This role involves leading and managing a team of quality assurance professionals, establishing and maintaining robust quality management systems, and ensuring compliance with all relevant regulations, guidelines, and standards. The Head of Quality Assurance will also be responsible for fostering a culture of quality and continuous improvement, as well as serving as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries.Applicants for the Head of Quality Assurance position must have a minimum of 10 years' experience in quality assurance within the pharmaceutical industry, with a strong background in leadership. A deep understanding of current Good Manufacturing Practices (cGMP), regulatory guidelines (such as FDA and EMA), and quality management systems is essential. The role requires excellent problem-solving, analytical, and communication skills, as well as a proven track record in managing regulatory inspections and audits. The ideal candidate will have a strong knowledge of pharmaceutical manufacturing processes, analytical techniques, and quality control methodologies, and the ability to collaborate effectively with cross-functional teams to integrate quality standards throughout the product life cycle.

Travel Percent
Less than 10%

Functions

• Medical Care/Hospital Administration