QMS Implementation Lead

Pauwels Consulting; Eigenbrakel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Pauwels Consulting seeks a QMS Implementation Lead to drive strategic quality transformations across global teams. You will translate regulatory requirements into actionable expectations and lead cross-functional sprints to redesign quality processes and documentation architecture for regulatory compliance and operational simplicity.

You will facilitate workshops with process owners, apply AI to regulatory analysis with expert oversight, and manage sprint governance while coordinating change

Qualifications

• Bachelor’s degree required.
• 8+ years of experience in biopharma with a focus on Quality Management Systems and GxP.

Responsabilités

• Lead the development of quality standards by translating regulatory requirements into actionable expectations.
• Direct cross-functional transformation sprints to redesign quality processes and documentation architecture.
• Facilitate workshops with global process owners to identify opportunities for harmonization and risk-based improvement.
• Utilize AI to support regulatory analysis while ensuring expert oversight and accuracy.
• Manage sprint governance, including scope, milestones, and decision-making in a matrix environment.
• Integrate change management, training, and communication into project solutions.

Connaissances

Quality management

Cross-functional leadership

Stakeholder engagement

Negotiation

Proactive communication

Formation

Bachelor's degree

Outils

Digital QMS platforms

Workflow tools

AI for regulatory analysis

Description du poste

Our client, a leading global biopharmaceutical organization, is seeking a QMS Implementation Lead to drive strategic quality transformations. The role focuses on leading cross-functional sprints to redesign quality processes and documentation architecture to ensure regulatory compliance and operational simplicity.

• Lead the development of quality standards by researching and translating applicable regulatory requirements into actionable expectations.
• Direct cross-functional transformation sprints to challenge and simplify current quality processes and documentation architecture.
• Facilitate workshops with global process owners and experts to identify opportunities for harmonization and risk-based improvement.
• Utilize AI capabilities to support regulatory analysis and drafting while ensuring expert oversight and accuracy.
• Manage sprint governance, including scope definition, milestone tracking, and decision-making in a matrix environment.
• Integrate change management, training, and communication needs into project solutions to ensure sustainable implementation.

• You have a Bachelor’s degree.
• You bring 8+ years of relevant experience in the biopharmaceutical industry with a deep focus on Quality Management Systems and GxP requirements.
• You possess expert knowledge in quality standards, controlled documentation, quality risk management, and inspection expectations.
• You have a proven track record leading cross-functional transformation sprints, including process-design and workshop facilitation.
• You bring experience with digital QMS platforms, workflow tools, and the application of AI for regulatory analysis.
• You are a proactive communicator with advanced negotiation and stakeholder engagement skills in a complex global matrix.
• You are fluent in English.

Nice to Haves

• Experience with data integrity principles and quality metrics reporting.
• Previous exposure to Lean or Agile methodologies in a regulated environment.