Analyze and understand the cloud compliance landscape:
Cloud customer expectations
Industry expectations and regulatory enablement
Competitive landscape
Quality standards, certifications, frameworks
Information security & privacy standards and frameworks
Regulatory Knowledge: A strong understanding of GxP regulations (such as GMP, GCP, and GLP) and guidelines from regulatory bodies like FDA, EMA, and ICH. This includes knowledge of industry-specific regulations and standards.
Risk Management Expertise: The ability to identify, assess, and mitigate compliance risks related to systems, processes, and data. Familiarity with risk assessment frameworks is key.
Documentation and Validation Skills: Experience in creating, managing, and reviewing detailed documentation, including validation protocols, reports, SOPs, and audit trails. Knowledge of CSV (Computer System Validation) is often critical.
Auditing and Inspection Readiness: Skills in conducting internal audits and preparing for external regulatory inspections. This includes managing CAPAs (Corrective and Preventive Actions) and addressing compliance gaps effectively.
Communication and Training: Strong communication skills to coordinate with cross-functional teams, provide training on GxP principles, and effectively communicate compliance expectations to stakeholders.
Customer Facing: Strong interpersonal and communication skills to liaise with customers, understand their compliance needs, and ensure alignment with GxP standards. The ability to explain complex regulatory requirements in a customer-centric manner is crucial.
Develop, maintain, and improve internal compliance processes and procedures.
Represent R&D on compliance topics with internal and external parties.
Requirements :
Bachelor’s or Master’s degree
3-5 years of relative experience in the area of Life Science & Health Care.
Software development lifecycle (SDLC) methodologies and best practices
Quality management practices and standards
Software testing and quality assurance best practices
Program and project management methodologies and best practices
Industry regulations and compliance expectations for software providers (e.g., GxP regulations for life sciences)
Risk assessment methodologies and best practices
Experience with the following:
Program and Project Management
Continuous Improvement / Process Improvement
Risk Management
Change Management
Customer Relationship Management
Excellent English language communication, verbal and grammatical skills
Proficient with Microsoft Office Professional (PowerPoint, Word, Excel, Outlook, etc.)
Familiarity with information security management best practices and controls including ISO 27001, ISO 27701, SOC 2 - desired
French multinational software company Dassault Systèmes SE creates software for manufacturing, simulation, and 3D product design, among other 3D-related applications. It was established in 1981, has 197 locations throughout the world, and its headquarters are in Vélizy-Villacoublay, France, employing 22,500 people.
With barely 20 engineers on staff when we first started in 1981, we catered mostly to the aerospace sector under the CATIA brand. Our workforce now numbers over 22,500, and we service nearly every industry you can imagine through our portfolio of 12 brands. Our DNA is science. We go with players all across the world as they use virtual universes to tackle the most pressing global issues. We do it all, and we're still expanding: 3D design, digital mock-ups (DMU), and product lifecycle management (PLM).
We have been using our knowledge and expertise to better comprehend and change the biological world since 2020; in other words, we are expanding our influence from things to life. By offering virtual twin experiences of the human body to the life sciences and healthcare sector, we may solve intricate puzzles and promote better health for people.