Beschreibung
- Start date: 16.10.2020- Latest start date: 02.11.2020
- End date: 09 months contract
- Extension: Yes, on request and showed performance
- Work location: Kaiseraugst , Basel
- Team: 5 – 10 Peers
- Workload: 100%
- Remote/Home Office: Yes / load will be discussed in the 2nd interview
- Traveling required: 5% max ( US )
Tasks & Responsibilities:
? 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 organization
? 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
? Characterize 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 Qualityteams
? Maintain an expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11.
? Be accountable for documentation, which may include, but is not limited to:
? System Risk Assessments
? Data Classification Reports
? User Requirements
? Validation Plans
? Validation Reports
? Validation Registries
? Requirements Traceability Matrices
? Test Plans
? Test Reports
? Functional and/or technical specifications
? Data and process flow diagrams
? Training documentation and/or work instructions
? Other Computer System Validation documents and related systems
? Drive resolution of business or systems issues.