Quality Assurance Manager Life Sciences

As a Quality Assurance Manager in Life Sciences, you will be responsible for ensuring GMP compliance for our Life Sciences clients and ISS Life Sciences quality standards and SOPs nationally. You will report directly to the Head of HSEQ Netherlands and functionally to Group QA, consisting of Regional QA Leads and the Global QA Director. Your tasks will include, among others:

• Implementing the annual global quality plan in country activities and setting up a Country QA manual;
• Approving Site SOPs and implementing changes from the global Life Sciences Quality Management System (LS QMS) to the Country LS QMS;
• Organizing training for Site QA Managers and handling critical and major deviations involving ISS personnel;
• Escalating any quality issues that cannot be resolved at the national level to Group QA;
• Developing an annual risk-based GMP audit plan for self-performed GxP services and GxP subcontractors used in the country and conducting audits within the country.

To perform this role, you have a bachelor's or master's degree in a relevant field and demonstrable experience in Quality Assurance within the Life Sciences industry. You have strong communication skills and can collaborate well with various stakeholders at different levels within the organization. Additionally, you have:

• Knowledge of quality management systems and standards, including GMP;
• Experience in conducting audits and working with quality standards and guidelines;
• Lead auditor qualification is a preference;
• CAPA management skills;
• Excellent analytical and problem-solving skills;
• A well-organized and structured approach;
• A flexible attitude and the ability to work under pressure.