Principal Consultant Life Sciences QMS TrackWise (m/w/d)

negotiable Expired 3 years ago
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About fme Life Sciences

fme Life Sciences is a leading provider of business and technology services supporting the deployment of Business Applications and Content Services/ECM solutions to its clients in the Life Sciences industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. fme is partnered with the leading ECM vendors supporting the Life Sciences industry, including Veeva, OpenText/Documentum, Sparta, Generis (CARA), Ennov and Alfresco.

fme’s priority is client satisfaction and assisting organizations with determining the most effective way to deploy mission-critical Content Services related technologies. We focus on both the business process aspects of technology platform implementations and integration of new trends, in addition to delivering high quality technical resources.

The Role

We seek a highly motivated professional with a track record of delivering Quality Management solutions to both large global and mid-market Life Sciences companies.

The candidate ideally having a strong background in the Life Sciences industry will become a key member of our Technology Services Practice. The applicant should possess strong analytical and technical skills, a robust and relevant background, strong communication abilities and have a team-oriented attitude.

The ideal candidate has exceptional verbal and written communication skills and must have the ability to converse with people from all levels within an organization. We are looking for a creative and dedicated individual who will fit with our collaborative culture.


  • Drive and manage implementation projects within the Quality Management area, e.g. QMS rollouts
  • Translate business requirements into design and configuration specifications
  • Work with the broader fme Life Sciences team to ensure successfulclient project engagements with high satisfaction levels to generate additional opportunities
  • Assume a mentoring role with the consulting team to increase team skills
  • Act as an SME for the internal services organization
  • Liaise with and build relationships with key individuals in the partner and client organizations
  • Engage with partners to understand their clients’ needs and match these to fme core competencies and capabilities
  • Work with partners to conduct solution presentations to end users and internal stakeholders
  • Collaborate with the fme Life Sciences sales and marketing teams to support the promotion of fme Life Sciences offerings
  • Serve as a primary point of contact for activities relating to the Quality Management area
  • Educate partners on the product and services portfolio offered
  • Develop a strong knowledge and understanding of the fme Life Sciences offering
  • Meet billable utilization requirements
  • Work independently as well as collaboratively as part of a larger team


  • 5-10 years of relevant experience in the Pharmaceutical/Life Sciences industry working in a consulting or professional services capacity
  • Very strong business process skills in the Quality Management space (QMS, GxP, FDA, ISO, CSV, etc.)
  • Solid knowledge of validation, documentation and auditing requirements and regulations in the regulated industry
  • Confirmed working experience with Sparta TrackWise and TrackWise Digital
  • Experience with Salesforce configuration and administration is beneficial
  • Proven track record of leading project teams and implementation projects globally
  • Experience with Document and Content Management systems is an advantage (e.g. Documentum, Veeva)
  • Experience with other QMS and DMS vendors is an advantage (e.g. Veeva Vault Quality, MasterControl)
  • Understanding of integration capabilities with LMS/QMS/DMS is valuable
  • Awareness and knowledge of Cloud SaaS offerings in Life Sciences industry is an advantage
  • Familiarity with Agile processes and methods is a plus
  • The candidate should be based in Europe
  • Excellent oral and written English skills, German proficiency is an advantage
  • Strong communication and presentation skills
  • Strong critical thinking and analytical skills
  • Successful track record of working cross functionally to drive initiatives and results within an organization
  • Highly driven, self-starter, strategic-thinking, energetic, strong problem-solving skills and the ability to communicate fme’s value to clients
  • Strong client-facing interaction skills with experience of engaging at all levels
  • Willingness to travel within Europe and as required outside the region (No travelling while Covid-19, only if unavoidable)
Curious? We would be happy to give you further insights into our company and your area of responsibility during a personal interview.

We are looking forward to meeting you!

Altstadt - Lehel


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