Beschreibung
Systems Validation Specialist (m/f/d)Are you an experienced Systems Validation Specialist (m/f/d) looking for a new project? Our client, a large pharmaceuticals company offers an interesting and exciting opportunity.
You should be willing to provide quality leadership and being deeply engaged with the business partners to have strong understanding of safety, clinical and medical data. As a main task, you will take are driving design, creation and adoption of validation strategies, ensuring data integrity and privacy to teams across the product development life-cycle.
Your role as Systems Validation Specialist (m/f/d)
- Concurrently manage multiple projects of diverse scope across functional areas
- Manage and deliver projects using agile and waterfall methodologies
- Able to articulate and facilitate the understanding of a system's intended use and it's compliance risk profile.
- Risk-based identification and classification of GxP systems
- Guide software project and product teams in understanding their role in establishing and maintaining the compliance of critical systems.
- Drive simplification and transparency across the organisation
- Manage compliance documentation processes including, but not limited to, System Risk Assessments (SRA) and Data Classification Reports (DCRs)
- Leverage the technical expertise of the internal teams and external technology providers and vendors to deeply understand the risk.
- Manage vendor risk
- Characterise for compliance purposes as-built and vendor provided business solutions that may involve automated systems and/or modifications to business processes.
- Engage with Procurement on acquisitions and assess compliance against internal expectation and SOPs'
- Assess outsourced vendors and clinical suppliers.
- Be a trusted partner for the Global Privacy Office, IT Security, and Business Quality teams
- Maintain an expert-level knowledge of the fast changing health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11
Required skills
- 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
Further information
- Location: Basel/ Basel-Land
- Start date: 16.10.2020
- End date: 30.06.2021 (9 months)
- Remote/Home Office: Yes - load TBA
Interested?
If you would like to apply for this pharmaceutical project as Systems Validation Specialist (m/f/d) please contact Hoa Ha phone for more information. Or you can apply directly by clicking the Apply button.
We are looking forward to your application.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.