Mantell Associates is partnered with a rapidly growing Biotech organisation on their search for a Head of Quality in Europe, who will be an integral member of the site leadership team. Do you hold over ten years of experience in a quality leadership role within the Biologics space?
This organisation is one of the most innovative players on the market, committed to maintaining excellence across complex biological products, process development, and clinical and commercial scale manufacturing, on a mission to advance global health. Formed a clear strategy to continue building capabilities and new facilities with the latest technology platforms to meet growing client needs.
Head of Quality Responsibilities:
Responsible for all aspects of Quality including Quality Management System (QMS) and Compliance.
Working cross-functionally and tracking projects from start to finish
Providing leadership and strategy to ensure that all products/services are aligned with quality standards, regulations (FDA and other notified regulatory bodies) and customer/regulatory requirements
Demonstrate knowledge of department practices and company policies, creating goals for the department and supervising/guiding internal audits to transform and create a site culture of compliance excellence - reporting to the top management on performances/improvements
Oversee team members and ensure performance levels meet corporate, Quality and business objectives
Head of Quality Requirements:
Bachelor’s degree and MSc or PhD in Biotechnology will be a huge advantage
Over 10 years of experience in leading Quality in a GMP environment (Biologics/Sterile or Aseptic)
Experienced in working closely with areas incl. Manufacturing, Engineering & PD
Extensive knowledge and proven track record of FDA and EMA regulatory requirements
Capable of applying GMP regulations and international standards to all aspects of the position
Mantell Associates is a specialist Pharmaceutical and Life Sciences Headhunting firm. For more information on this role, please get in touch with Onur Dilek at firstname.lastname@example.org.