Pauwels Consulting Logo

Senior Expert – GMP Certification & Pilot Plant Qualification

Life Sciences
QA
Location
Braine-l'Alleud, Walloon Brabant
Work type
Consultancy
Work model
Fulltime, Hybrid

Responsibilities

Key Responsibilities

  • Lead and drive the end-to-end GMP certificationfor Pilot Plant facilities, ensuring readiness for clinical batch manufacturing in compliance with FDA and EMA regulatory requirements.
  • Act as the subject matter expert (SME) for GMP compliance within R&D Pilot Plant operations, advising senior leadership and cross-functional teams on regulatory expectations and risk-based decision making.
  • Define, develop and execute qualification and validation strategies leveraging existing structure, including:
    • Facility and cleanroom qualification update
    • Equipment qualification and lifecycle management
    • Process validation strategy for clinical manufacturing
    • Environmental monitoring programs and contamination control strategies
  • Lead preparation for and participation in regulatory inspections and audits (FDA, EMA, notified bodies), including inspection readiness, hosting inspectors, and managing responses to observations (e.g. CAPAs, audit findings).
  • Establish and implement the GMP framework and quality systems required to transition R&D Pilot Plant activities into compliant clinical production (IMP manufacturing).
  • Provide strategic oversight and hands-on leadership in the certification of production lines, cleanrooms, and controlled environments, ensuring alignment with Annex 1 and applicable guidelines.
  • Drive the review and approval of GMP documentation, including validation master plans, qualification protocols/reports, SOPs and regulatory submissions.
  • Partner with Pilot Plant, Quality, Engineering, and Manufacturing teams to ensure robust, inspection-ready operations and continuous improvement of GMP practices.
  • Assess gaps against regulatory expectations and lead remediation and compliance programs to achieve and maintain certification status.

    • Qualifications & Competencies

    • Recognized expertise in GMP regulations and compliance frameworks (FDA, EMA, ICH, EU GMP, Annex 1).
    • Proven ability to lead complex certification and validation programs in regulated environments.
    • Strong track record in:
      • Cleanroom and controlled environment certification
      • Equipment qualification (from design through lifecycle)
      • Process validation and technology transfer to GMP manufacturing
  • Extensive experience with regulatory inspections and audits, including direct interaction with inspectors and successful inspection outcomes.
  • Demonstrated capacity to define strategy, influence stakeholders, and drive execution in cross-functional and matrix environments.
  • High level of autonomy, critical thinking, and decision-making in a risk-based GMP framework.
  • Ability to manage multiple high-impact initiatives and ensure delivery under demanding timelines.

    • Requirements

    • Master’s degree or higher in Mechanical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or related scientific field.
    • Minimum 8–10 years of experience in GMP-regulated environments, with significant exposure to facility qualification, validation, and regulatory inspection readiness.
    • Strong experience within pharmaceutical, biotech, or medical device industries, ideally in clinical or pilot-scale manufacturing environments.
    • Demonstrated track record of successful GMP/IMP certification projects, including facility commissioning and approval for clinical batch production.

    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.
    # 100966
    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.
    Rebecca Lagadec

    Rebecca Lagadec

    Email
    rebecca.lagadec@pauwelsconsulting.com
    Phone
    +32460252024