Job description
Job Summary:
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.
Key Responsibilities:
- 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.
Qualifications & 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.
Preferred Competencies:
- 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.
Why joining us?
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.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!