Manager Quality Systems

The company seeks a Manager Quality Systems in Yverdon-Les-Bains to oversee daily quality operations, lead compliance initiatives, and manage the QA team for its Swiss manufacturing facility.

This position is responsible for directing the day-to-day functions of the Quality Management System at the Swiss manufacturing site. The role operates within the Quality Assurance department and focuses on maintaining regulatory compliance while supporting continuous improvement efforts across the organization.

Responsibilities

• Oversee daily operations of the Quality Management System for the Swiss manufacturing site.
• Monitor biopharmaceutical quality compliance and identify potential risk areas for escalation.
• Prepare data for the Quality Management Review (QMR) and lead the corresponding meetings.
• Represent the Bioplant Quality Assurance function in global quality system initiatives.
• Lead or participate in continuous improvement projects to enhance operational efficiency.
• Manage the Bioplant Quality champion community across all departments.
• Administer the electronic Quality System on a daily basis for the Bioplant.
• Manage core quality processes, including quality management reviews, documentation, archiving, training, deviations, CAPAs, and change control.
• Lead inspection backrooms and act as a scribe when necessary.
• Serve as the primary site subject matter expert for assigned core quality processes.
• Manage the QA System team related to QS activities.
• Manage and organize activities to ensure compliance use of QMS.
• Monitor and report quality compliance indicators for the QA department.
• Chair quality compliance reviews in the department.
• Implement quality compliance initiatives in the department.
• Coach and support other team members for quality compliance matters.
• Coordinate the department inspection readiness.
• Act as a primary site SME for Artificial Intelligence projects related to Quality Systems.
• Participate in internal audits and Gembas.
• Act as a QA approver for document changes, deviations, and CAPAs.
• Drive resolution of major quality issues.
• Work in a right first time and site inspection readiness approaches.
• Work in view of the site readiness for regulatory inspections.
• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as company guidelines.
• Serve as a QA representative for IA topics.

Requirements

• Bachelor's Degree in a relevant field such as Pharmacy, Chemistry, Biology, or Bio-engineering.
• Relevant years of experience in Quality Assurance in a GMP environment.
• Proficiency with electronic Quality System administration.
• Advanced expertise in good practice requirements GMP as well as biopharmaceutical industry regulations and standards with Quality Systems.
• Experience in health authorities inspections.
• Ability to exercise quality decisions in a pragmatic and compliant decisions.
• Strong result orientation and committed team member.
• Must speak, read & write in both English and French.
• Excellent written and verbal communication skills.

About the company

The company fosters an inclusive environment that welcomes diverse perspectives and encourages collaborative work. It is dedicated to maintaining a high standard of quality within its departments and actively contributes to a strong culture of business integrity and ethics.

• Welcomes diverse perspectives and inclusive collaboration.
• Drives a high level of quality in the department.
• Contributes positively to a strong culture of business integrity and ethics.