QA Manager Compliance

We are looking for a QA Manager to develop and manage a new department within our Quality Assurance unit. The Compliance manager will report to the QA Director. We are looking for a motivated and dedicated person which will work with the team to develop and strengthen the Compliance for the site. The QA Compliance manager will be responsible for the quality compliance program at Fresenius Kabi AS, Halden. This includes management of the supplier program; management and execution of the self-inspection program; management, development and implementation of Quality on the shopfloor; management of the external auditing and inspection program and the legal compliance program at the site.

Main responsibilities

• Responsible for management, development and oversight of the quality compliance team.
• Maintain process for Legal Compliance in the site by monitoring regulations related to pharmaceutical industry (ICH, cGMP, pharmacopeia and national regulations), ISO-standards and corporate regulations
• Communicates observations from self-inspections and ensures that relevant responsible persons implement appropriate CAPA to address the observations.
• Responsible for the external audit/inspection program, including hosting and facilitating external audits/inspections.
• Qualify as Lead auditor for internal and external audits
• Participate and host external audits/inspection at the site
• Support the site organization with training in the respective quality systems
• External presentation and communication towards customers, authorities and corporate organization in topics related to quality assurance and compliance topics.

Requirements to education, experience and personal characteristics

• Master degree in Chemistry, Biology or Pharmacy
• 3-5 years’ experience in a Management position with personnel and budget responsibilities.
• Documented 3-5 years’ experience in ISO/cGMP quality systems
• Excellent ability and high interest in using, managing and developing IT-systems for Quality Assurance.
• Excellent skills in writing and speaking Norwegian and English.
• Experience from an international company with cooperation and communicating in different levels in the organization.
• Personnel skills: Proactive, good in cooperation and communication, dedicated and able to motivate the team.

If you would like more information about the position, please contact QA Director Anne-Mette Horsrud Akre, tel: +47 69 21 11 00.