Company : Baxter Location : Lessines Wallonia From : Talent BE
Together, we create a place where we are happy, successful and inspire each other.
This is where you can do your best work.Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.About The roleAt Baxter, we are passionate about saving and sustaining lives by finding solutions to complex problems.
Every single day, the manufacturing team strives to build quality products for our customers—and are oftentimes met with unforeseen problems to solve.
The talents at Baxter meet these challenges head-on, as a team, in an effort to build products with the customer’s needs top-of-mind.Your team at BaxterAs Quality Systems and Compliance Lead you report directly to the Director of quality and provide leadership and strategy to ensure the development, implementation, and lifecycle management of Baxter quality system in line with the Baxter’s global QMS and drive compliance strategy for the site ensuring inspection readiness at all times along with a team of quality professionals.
The QS & Compliance lead reports directly to the Site Quality Head of BaxterLessines.What you will be doing:
Manage the quality team and lead improvement initiatives identified to improve Quality Management processes, associated systems, stakeholder engagement and their efficiency.Orchestrate and ensure continuous alignment with principles and ways of working of QMS across the different functional areas through engaging with key partners, functional teams, and Process Owners.Strengthen the quality (including data integrity) culture in the supporting departments by providing mentoring and/or training on cGMP requirements and support quality review meetings governing quality & compliance as well as the operational business performance.Develop and nurture an environment ofinnovative thinking and the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality/compliance and operational performance.You support and act as spokesperson during health authority inspections, customer audits and internal Baxter audits.Be the Quality Lead for appointed vendors in excipients, API’s and Packaging and be responsible for labeling and ensure that it follows the applicable standards.Your ProfileBachelor’s degree or equivalent in chemistry, pharmaceutical Sciences or related scientific field is required.
Having a registered QP number is an asset.You have a comprehensive understanding of cGMP (local and internal) and ICH GuidelinesYou have experience with regulatory inspections and preparedness.Ability to work independently in a multifaceted environment, balance multiple tasks and collaborate effectively.You have experience of leading a team of experts and enjoy supporting, mentoring, and developing team members.You are a proven leader who enables creative thinking and drives implementation of concepts into practical business solutions within a GMP framework.Delivers dedicated timelines.Proficiency in French and English Baxter LessinesWallonia
