​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.

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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

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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 onur.dilek@mantellassociates.com.