Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
Responsibilities
- Execute compliance activities for systems, such as plans, reports, tests, changes, periodic reviews, and deviations
- Provide necessary support to meet regulatory and information security requirements for regulated systems projects
- Serve as the primary contact for CSV-related matters for GxP-computerized systems and act as a liaison between technology-based solutions and the IT Compliance on IT GRC unit
- Review and approve project-related documents for GxP relevant systems, including determining GxP-applicability for all GxP- and non-GxP relevant systems
- Establish a trusted partnership with the assigned IT technology-based function, understanding business drivers, and provide required day-to-day operational support
- Review and approve GxP-impacted deviations, ensuring appropriate CAPA implementation
- Contribute to the preparation of compliance strategies and execute plans for systems associated with respective functions
- Review and approve periodic review reports for GxP computerized systems and manage any gaps within the CAPA management system
- Provide audit support as assigned and offer necessary compliance support for any resulting CAPAs
Requirements
- University degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent level
- A minimum of 3 years of overall IT experience
- A minimum of 5 years of relevant experience in the pharmaceutical industry and in particular within regulated functions such as IT quality and compliance
- Solid understanding of global regulations and health authorities’ expectations governing computerized systems (CSV, Part 11, etc.)
- Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments
- Experience in quality management of premises and cloud-based regulated environments
- Highly experienced in the operational management of GxP-solutions, including its related technologies to support the operation
- Good understanding in system application management, its quality support approach and industry best practices (ITIL, ITSM, etc.)
- Experience in the development, implementation and lifecycle management of key computerized systems in pharmaceutical development, manufacturing, quality, commercial and infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.)
- Strong analytical and problem-solving mindset and the ability to think critically and strategically
- Proficient conflict management skills to mediate and resolve disagreements between stakeholders
- Excellent written and verbal communication skills for clear communication, content delivery, and stakeholder interaction.
Benefits
- flexible hours
- vacation account
- Digital Learning
- Performance & talent development
- leadership development
- Apprenticeships
- LinkedIn Learning
- Company bike
- Job ticket
- Deutschlandticket
- Employer-funded pension
- Childcare
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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