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Critical Deviation Investigations Manager

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Amaris Consulting

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Location:
Belgium , Bruxeles

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Category:
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Contract Type:
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Salary:

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Job Description:

The Critical Deviation Investigations Manager is responsible for leading, managing, and ensuring the scientific rigor and regulatory compliance of investigations into critical generalist deviations across all stages of pharmaceutical manufacturing, packaging, testing, and distribution. This role ensures that all deviations impacting product quality, patient safety, or regulatory compliance are thoroughly investigated, root causes are identified, and effective corrective and preventive actions (CAPAs) are implemented and verified. The incumbent will serve as a key quality leader, driving continuous improvement in deviation management systems and supporting readiness for internal audits, regulatory inspections (FDA, EMA, MHRA, etc.), and regulatory submissions.

Job Responsibility:

  • Lead end-to-end investigations of critical deviations across manufacturing, packaging, laboratory testing, storage, and distribution processes
  • Conduct or oversee root cause analysis (RCA) using validated methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis, FMEA) to ensure scientifically sound conclusions
  • Ensure all investigations are completed within defined timelines and in full compliance with GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), ICH Q10, FDA 21 CFR Part 211, and EU GMP Annex 1 & 15
  • Author and review detailed Investigation Reports, Deviation Logs, CAPA Plans, and Final Closure Reports with clear evidence and traceability
  • Collaborate with cross-functional teams including Manufacturing, R&D, Packaging, QA, QC, Regulatory Affairs, and Supply Chain to gather data and implement solutions
  • Manage and mentor junior QA personnel involved in deviation investigations
  • Monitor and analyze deviation trends to identify systemic risks and recommend proactive quality improvements
  • Ensure CAPAs are effectively implemented, monitored, and verified for closure
  • assess effectiveness through follow-up audits and data review
  • Support internal and external audits and inspections by providing clear, documented evidence of investigation processes and outcomes
  • Maintain up-to-date knowledge of evolving regulatory expectations and industry best practices (e.g., from PIC/S, ISPE, PDA, and EMA guidance documents)
  • Contribute to the development and improvement of the company’s Quality Management System (QMS), particularly in deviation management and CAPA processes

Requirements:

  • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Biochemistry, Chemical Engineering, or a related field
  • Master’s or PhD preferred
  • Minimum 5–7 years of experience in pharmaceutical in deviation investigations and CAPA management
  • Proven experience in managing critical deviations in a regulated environment (GMP, FDA/EMA compliant)
  • In-depth understanding of GMP regulations, ICH guidelines, and regulatory inspection expectations
  • Experience with electronic quality systems (EQS) such as MasterControl, SAP QM, TrackWise, or similar
  • Strong analytical, problem-solving, and decision-making skills
  • Excellent written and verbal communication skills
  • ability to present findings clearly to technical and non-technical audiences
  • Leadership and mentoring experience with QA teams or cross-functional groups
  • Fluency in English (required) and French Mandatory

Nice to have:

  • Experience in risk-based thinking and quality risk management (QRM)
  • Familiarity with change control, product recall, and batch release processes
  • Certification in Six Sigma, Lean, or CAPA Management is a plus
  • Experience in multinational pharmaceutical organizations or CRO/CDMO environments
What we offer:
  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Additional Information:

Job Posted:
January 08, 2026

Employment Type:
Fulltime
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