QMS Implementation Lead

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.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
• Werk waar en wanneer je het beste presteert voor een ideale werk-privébalans.
• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.