Senior Quality Assurance Manager

• Supervising all activities at plant level as related to Operational Quality, Complaints and Release
• Assure escalation of any potential FA and gather data to assist FA process
• Support product release by ensuring timely review and investigation of deviations related to the manufacturing process
• Support NCR and CAPA process: root cause identification and continuous improvement
• Ensure timely documentation and closure of NCR, CAPA and complaint records
• Ensure timely investigation and response to ICARs
• Review and assess process and documentation change requests
• Participate in internal and external quality system audits conducted by the corporate or regulatory agency representatives
• Collaborate with ICO partners for projects or issue resolution (intracompany)
• Support quality systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives
• Ensure training is completed for area of control
• Perform reporting of KPI as applicable (CAPA review board, Management Review…)
• Support 6s program
• Response Quality on the shopfloor during visits / audits
• Manage, support and develop the Operational Quality, Complaints and Release teams
• Monitor KPI and take action to meet target for the department.

• Bachelor’s degree in a relevant scientific discipline
• advanced degree preferred
• Minimum of 10 years of experience within the pharmaceutical industry, with progressively increasing levels of responsibility
• Minimum 5 years of experience in people management
• Fluency in French and English is a must
• Being recognized as Qualified Person, as defined in the Directive 2001/83/EC for Medicinal products and as defined in DIRECTIVE 2001/82/EC for veterinary medicinal products is an added value
• Problem-solving and analytical skills
• Critical and inquisitive mind
• Excellent communication and presentation skills
• Resistant to stress & demonstration of flexibility in times of change.

Being recognized as Qualified Person, as defined in the Directive 2001/83/EC for Medicinal products and as defined in DIRECTIVE 2001/82/EC for veterinary medicinal products.

• Support for Parents
• Continuing Education/Professional Development
• Employee Health & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer.