QA Team Leader

About the Role
As the head of the QA team you’re expected to establish a quality assurance system for the development and production processes in the company’s facility, working in compliance with the regulatory standards of various regulatory authorities. You will lead and monitor the staff, manage and construct work protocols, document work procedures and practices and make sure they are in line with manufacturing practices.

About You

• PhD in life sciences
• 3+ years of industrial experience in the biopharmaceutical world.
• Experience with animal cell biology.
• Experience with the FDA and/or EFSA – Preferred.
  Responsibilities

• Responsible for the preparation of regulatory agencies applications, reports, and communications worldwide
• Manage activities such as audits, regulatory agency inspections.
• Formulate and implement quality and regulatory affairs policies and procedures to ensure that quality and regulatory compliance is maintained.
• Provide quality and regulatory guidance regarding design, development, evaluation, and marketing of products.
• Oversee and assure quality processes of manufacturing activities – in-house and at the manufacturing plant.