Quality Operations Lead

The Quality Operations Lead reports to the Associate Director Quality and is responsible for the maintenance and certification of ensuring continued license to operate with full compliance with prevailing regulations.

• Leads and manages the Quality team, ensuring training and development of team members to meet business needs
• Process owner for the Quality Management Process
• Ensure the QMS is established, compliant and maintained to current GMP, GDP and ISO certification governing the different status of products and organizations
• Identify gaps and areas of improvement in QA processes and lead relevant actions and initiatives of improvement
• Responsible for training oversight of the QMS
• Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
• Ensures Good Documentation Practices
• Responsible for the management of the Quality Management System and its eDMS
• Responsible for the follow up of KPIs
• Contribute to the management and investigation of non-conformances and their related CAPA (s)
• Responsible for ensuring that the yearly audit plan is prepared and performed
• Ensure the coordination of the Change Control Process for all Products (Change control boards and monthly review preparations and continuous improvement)
• Host and Support all Internal and externals inspections
• Prepare the Management reviews and support their presentation. Document and follow up any action for improvement including the Quarterly Management Reviews (QMRs), as appropriate
• Contributes to strategic direction and is action oriented to deliver results
• Monitor the quality processes and ensure the KPIs targets related to the quality processes are met

• Master's degree + 5/6 years minimum degree in science related subject and quality
• Skills in EU GMP and GDP, ISO13485 and 22716 standards
• Experience working in a GxP environment
• Eligible to act as deputy quality PRRC

We love our offices and the setting they provide for in person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.