In order to continue supporting our clients with their future challenges, we are looking for a colleague to join our CGI’s Life Sciences team.
CGI works with life sciences companies all over the world to deliver better business outcomes. Through our deep industry expertise, we help pharma, biotech, and medical device firms transform their businesses to drive high performance, compliance and digital connectivity. CGI empowers quality and manufacturing teams to realize competitive advantages increasing efficiency, safety standards, and reducing costs and time to market. For us, partnership and quality are both a philosophy and a way of life.
You bring in expertise and experience in Regulatory & Quality across GxPs to support compliance obligations for customers within the broader MedTech and/or Pharma industry. You are a trend watcher, following the latest updates in regulations and technologies in the life sciences. Last but not least, you will play a leading role in building out CGI’s European life science quality Hub by leveraging on our global network of quality experts.
Your future duties and responsibilities:
• Provide QA/regulatory advice (ISO, MDR / IVDR, GxP, …) and define and deploy the roadmap to guarantee compliance
• Be responsible for implementing and improving quality management systems (QMS) and their associated processes
• Understand concepts of process harmonization to support controlled document management across an organization; such as SOP harmonization.
• Be working with multiple stakeholders within QA/QC, Supply Chain, Process / Validation, R&D, Manufacturing, Medical Affairs
• Conduct internal audits and provide guidance regarding best practices and continuous improvement
• Possibly interact directly with government entities on behalf of our clients(e.g. FDA, EMA, notified bodies, ..)
• Support our global life science practices by participating and providing updates on what’s happening within the regulatory & quality landscape)
• Assist in business development, marketing/pre-sales activities and VIP meetings with prospective clients.
Required qualifications to be successful in this role:
• a Master/bachelor of Sciences (Biosciences, Biomedical sciences, Biology, Pharmaceutical sciences, Chemistry) or a Master of Industrial or Civil Engineering or
• a professional with 7+ years of experience
• able to approach challenges and solve problems in a methodical manner
• a strong communicator, verbal and written
• stress-resilient, solution-oriented and able to cope with change
• Connecting the dots / innovative thinker
• proficient in English and Dutch/French
• trusted with GxP (preferably GMP or GCP) requirements
• a professional with profound knowledge of ISO standards (preferably ISO13485, ISO14971…), MDR, IVDR, MDSAP and other guidelines (e.g. 21 CFR part11/part 820/210 & 211, …)
• experienced in QMS implementation
• familiar with development of SOPs, related WIs, forms, checklist, protocols, and reports- SME in controlled document management.
Cherry on the cake :)
• certified in Project Management methodology e.g. CAPM/PMP/Prince2/ Agile/Scrum/Safe…
• user experience in QMS systems (such as VEEVA, TrackWise, MasterControl or other)
What we offer
Ownership, listening, recognition, health and well-being and a competitive benefits program.
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com.
No unsolicited agency referrals please.
CGI is an equal opportunity employer.