Systems Validation Specialist

System Validation Specialist

On behalf of one of our clients, a leading pharmaceutical company, we are looking for a System Validation Specialist. This is a 9- month contract located in Basel, Switzerland.

General information

• Start date:16.10.20
• End date: 9-month contract
• Extension: possible
• Work location: Basel
• Workload: 100%

Background

Your primary accountability is to provide quality leadership. By being deeply engaged with our business partners, you will develop a strong understanding of safety, clinical and medical data; you are driving design, creation, and adoption of novel validation strategies, ensuring data integrity and privacy to teams across the product development lifecycle. You will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.

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 its 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 Quality teams
• 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 specification
  • 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.
    

Must Haves

• 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

If you are a result-oriented System Validation professional looking for a challenging new position that applies to your skills, then we look forward to receiving your application!

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