Qs and Compliance Manager - Lessines, België - BAXTER

BAXTER
BAXTER
Geverifieerd bedrijf
Lessines, België

4 weken geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

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.

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
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.

For our Lessines plant, we are looking for a


Quality Systems and Compliance Lead

About The role


As Quality Systems and Compliance Lead you provide leadership and strategy to ensure the development, implementation and lifecycle management of Baxter Lessines 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 Baxter Lessines.


Your main responsibilities are:


  • Lead improvement initiatives identified to improve Quality Management processes, associated systems, stakeholder engagement and their effectiveness.
  • Orchestrate and ensure continuous alignment with principles and ways of working of QMS across the different functional areas through engaging with key stakeholders, functional teams, and Process Owners.
  • Strengthen the quality (including data integrity) culture in the supporting departments by providing coaching and/or training on cGMP requirements.
  • Support quality review meetings governing quality & compliance as well as the operational business performance. Identify trends and define actions ensuring continuous improvement.
  • Develop and foster an environment of
    innovative 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, including:
  • Ensure Inspection readiness (Audit preparation, schedule and manage mock inspections, SME coaching)
  • Prepare/review site response and associated CAPA plan for Health Authority and/or customer audits.
  • Be the Quality Lead for appointed vendors in excipients, API's and Packaging.
  • You are responsible for labeling and ensure that it complies with the applicable standards.
  • Remain current in knowledge and skills towards regulatory and industry trends.
  • You are leading a team of quality professionals and will ensure the growth, development and retention of talents.

Profile

  • A minimum of bachelor's degree 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 Guidelines
  • You have experience with regulatory inspections and preparedness.
  • Ability to work independently in a dynamic environment, handle multiple tasks and collaborate effectively.
  • You have experience of leading a team of experts and enjoy supporting, coaching 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 commitment timelines and has high sense of urgency.
  • Fluency in French and English

Reasonable Accommodations

Recruitment Fraud Notice


Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.

To learn how you can protect yourself, review our Recruitment Fraud Notice.

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