Pauwels Consulting Logo

Senior Project Lead – Qualification, Handover & Operational Readiness

Life Sciences
QA
Master
Expert (10+)
Location
Braine-l'Alleud, Walloon Brabant
Work type
Consultancy
Work model
Fulltime, Hybrid

Our client, a leading life sciences organization, is seeking a senior leader to oversee the final phase of a major manufacturing project. This role ensures a compliant transition from capital project delivery to operational readiness through structured qualification and documentation closure.

Responsibilities

  • Lead the integrated project team through qualification, verification, and documentation closure to enable a controlled transition to operations.
  • Translate project priorities into execution roadmaps with clear governance routines and escalation paths.
  • Drive completion of qualification activities across systems, equipment, and utilities in alignment with start-up needs.
  • Coordinate audit readiness plans to ensure project documentation and evidence packages are defensible and available for health authority inspections.
  • Manage snag-list finalization and operational handover, ensuring all packages are accepted by the receiving organization.
  • Provide hypercare support during the initial months of production to resolve complex cross-functional start-up issues.

Requirements

  • You have a Master's degree in Engineering, Life Sciences, Biotechnology, or a related technical field.
  • You bring 8+ years of experience in pharmaceutical or biotech manufacturing with a focus on large-scale CAPEX project delivery.
  • You possess expert knowledge in final-phase project execution including qualification, verification, and operational handover.
  • You have a strong background in GMP start-up processes and inspection readiness within regulated environments.
  • You're an experienced leader capable of making pragmatic, compliant decisions while managing complex cross-functional stakeholders.
  • You are fluent in English.

Nice to Haves

  • Experience in biotech, biologics, or advanced therapy manufacturing.
  • Exposure to European health authority inspection preparation.
  • Willingness to obtain or possess certification in Project Management or C&Q.

Offer

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
# 101514
With a plus sign and country code (e.g. +32 400 00 00 00).
We accept Word and PDF files up to 3 MB.
Candidates must be legally authorised to work in the EU and possess the required language skills for the job location.
Chat with Alex
Not sure if this job is right for you? Chat with Alex, our AI career coach, and discover the vacancies that match your profile.