Vacancy expired!
- CISSP/CISA/CISM/CRISC/CGEIT/ITIL or equivalent certification is desirable.
- Bachelor's degree
- 5-7yrs experience
- Experience in analyzing business processes for compliance, effectiveness, and efficiency.
- 5+ years of project management experience, ideally in information Technology, Security
- Experience in Electronic Document Management Systems (e.g., OpenText) preferred.
- Proven track record of success in driving complex, multi-stakeholder and cross-functional projects with tight deadlines and business critical deliverables.
- Strong communication skills for effective stakeholder engagement and consensus building.
- Exceptional planning, organization and time-management skills including project management tools.
- Knowledge of GxP, FDA Validation and CFR 21 Part 11
- Proficient in Microsoft Office applications - Teams, O365, SharePoint, etc.
- Works creatively to anticipates and meet deadlines while being reliable and accountable.
- Will be working on Data Integrity projects.
- Data is GxP data - which typically includes clinical, r&d, manufacturing.
- Data is subject to regulations and must be accurate PM - needs to have core PM skills and ideally data integrity experience, or CSV or software assurance background.
- The geographic scope is Global and includes all R&D Sites - Melville (USA), Blaine (USA), Shanghai (China), Toronto (Canada), Paris (France), Seoul (South Korea) and Tokyo (Japan).
- Managing governance of processes, access, SOPs, and documentation to ensure compliance.
- Co-ordinating with the R&D Sites to ensure robust operationalization & Implementation of DI policies, standards, and guidelines.
- Representing R&D on the Global Data Integrity Core Team for R&D DI execution activities.
- Requires analysis of business processes - identifying gaps and formulating remediation options - that will warrant robust processes governed by SOPs/ WKIs.
- The individual is required to closely collaborate with R&D QA for an effective Data Integrity (DI) landscape. The scope includes
- Ensures adherence to FDA Validation, CFR 21 Part 11 and Change Control management processes requiring knowledge of controlled documents inclusive of Change Control, CAPAs and Deviation procedures.
- Coordinate vendor support: Drive requirements gathering and scoping of projects to development SOWs for vendor engagement.
Vacancy expired!