Systems Validation Specialist
Posted on Sep 23, 2020 by NextLink Solutions
NextLink are currently working with a global pharmaceutical organisation who are seeking an "Systems Validation Specialist" on an initial 9-month contract on a Remote basis.
(This role can also be based at the client site in Basel, CH (Switzerland) should the successful candidate prefer.)
Start date: ASAP
Latest start date: 16.10
End date: 9 months
Work location: Basel, CH
Remote/Home Office: home office but some onsite is to be expected (will be discussed within the team)
- BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable(*)
- At least 10 years of related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD, Data Privacy(*)
- 3+ years in a technology role IT or Data(*)
- Program or IT Project management experience(*)
- Expert knowledge of Software Development Life Cycle methodologies, inclusive of Agile. (*)
- Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact(*)
- Strong English and German communication skills (nice to have) -- ability to communicate complex information, issues, and potential solutions at an executive level(*)
- Proven skills in relationship building, customer-focus, decision-making, and problem solving.
- Demonstrated ability to quickly learn business priorities in unfamiliar or ambiguous areas.