As the primary responsible person of the Quality department, consisting of Quality Assurance, Regulatory Affairs and Quality Control, you will provide leadership and management for all Quality activities to ensure that quality systems and products are effective and in compliance with regulatory expectations and quality standards. The position of Manager/Director Quality Operations is a highly visible role within the company and involves contact with multidisciplinary teams within our international company.
I am looking for a dynamic leader who combines strategic view with operational hands on mentality and can make our quality management processes leaner and pragmatic. The Manager/Director Quality Operations is reporting to the Board of Directors. For the main part you will be working from Nijmegen and Amsterdam. In addition the position requires national and international travelling across Europe (Approximately 20%-25%).
Do you combine biotechnical knowledge with leadership and project management skills and feel comfortable within an internationally growing organisation? Then you might be interested in this position.
Main activities and responsibilities
- Ensure compliance to regulatory requirements including QMS standards;
- Lead and develop staff within the area to a high level of competency;
- Further develop and implement the QMS culture within the company;
- Ensure the quality and regulatory compliance of the facility is maintained through an effective monitoring program;
- Integration QMS of subsidiaries into corporate QMS;
- Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process;
- Ensure that validation system is in compliance with relevant external (regulatory) requirements including ISO 9001 and GMP.
- Prepare the site for, and host, external audits (customer/regulatory) ensuring corrective/preventative actions are put in place to address non-conformances;
Qualifications and experience
- A Masters or Bachelors degree in Biochemistry, Biotechnology or equivalent. Post graduate or Masters in Quality Management is a plus;
- At least 5 years of management experience in Quality Assurance and Regulatory Affairs, preferably in the pharmaceutical, medical device and/or tissue sector;
- Demonstrated experience with: Class 3, implantable Biomaterials, Class 3, titanium implants, Pharmaceuticals and/or human and animal derived tissue;
- Demonstrated experience in interacting with regulatory bodies such as EMA, US FDA, ANVISA and the like – for registration of products as well as manufacturing compliance;
- Broad experience with regulatory requirements, including ISO-9001, ISO-13485, GMP en GDP;
- The position requires a hard-working, ambitious and creative individual, with strong analytical and leadership skills;
- Excellent communication skills (verbal and written) in English and Dutch; knowledge of German is a plus.