(Senior) Project Manager GMP Annexe 1

☞ AETHER

Visualizza: 105

Giorno di aggiornamento: 03-12-2025

Località: Wavre Walloon Brabant

Categoria: Pianificazione / Progetti IT - Software

Industria: Business consulting Services

Posizione: Mid-Senior level

Tipo di lavoro: Full-time

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Contenuto del lavoro

For sure, you already know the chaos that can result from neglecting sterile compliance in pharmaceutical production. A single misstep in Annex 1 implementation can lead to regulatory shutdowns, batch losses, or worse—compromised patient safety. You’ve probably lived through the consequences more than anyone else. That’s exactly why this mission requires someone like you.

Success of Engineering Projects mostly relies on key individuals demonstrating Intrapreneurial Leadership, and the best way to develop these skills is through hands-on consulting roles—working alongside established intrapreneurs in international companies, contributing to managing stakeholders’ engagement, workflows’ reliability, or solutions’ sustainability.

Join AETHER to support Intrapreneurial Projects as a Project Manager - Annex 1 Compliance:

The Experience We Are Actively Looking For

  • At least 5 years in a pharmaceutical industrial environment with a focus on sterile production.
  • Strong expertise in Annex 1 requirements (2022-2023 version) and sound understanding of GMP challenges.
  • Autonomous and proactive field approach, with an ability to collect insights from all corners of the organization.
  • Proven ability to collaborate across production, quality, maintenance, and engineering departments.
  • Solid experience in managing technical projects, ideally within aseptic or cleanroom environments.
  • Natural leadership, organized mindset, and diplomatic coordination style in complex settings.
  • Pragmatic, action-oriented personality, capable of driving regulatory transformation.

Responsibilities

The scope of this intrapreneurial project is to lead Annex 1 compliance initiatives in a sterile pharmaceutical production environment. The Key responsibilities expected from our consultant might include:

  • Define the implementation plan based on a gap analysis, with priorities set through risk management.
  • Lead and manage complex, long-term projects with regulatory impact.
  • Design technical solutions in collaboration with subcontractors.
  • Define project needs and establish the budget envelope.
  • Launch and oversee the operational implementation of compliance projects.
  • Conduct field investigations and collect data from production and cross-functional teams.
  • Facilitate interactions and build trust within multi-disciplinary teams.
  • Coordinate all stakeholders to ensure alignment and smooth execution.
  • Defend and present project proposals to the steering committee.
  • Conduct post-implementation follow-up to monitor project performance and outcomes.

Your best career choice will be one that propels you toward becoming a future intrapreneur or entrepreneur in your field of expertise.
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Scadenza: 17-01-2026

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