About the Role: 
Location: 100% remote but should be in EST time zone
Length of Contract: 1 year+
Hourly Rate: $70 per hour W2 (no Corp to Corp)

About the project: Data is subject to regulations and must be accurate, This team builds internal policies and procedures around FDA policies.
This person – will continue to make sure we keep technical documentation accurate and updated, will update proper SOPs, etc. Will be updating technical documentation and modifying where needed

• Experience in analyzing business processes for compliance, effectiveness and efficiency.
• Experience in writing technical/compliance process documentation, SOPs and training.
• Strong communication skills for effective stakeholder engagement and consensus building.
• Experience in project management a plus.
• Experience in Electronic Document Management Systems (e.g. OpenText) preferred.
• Knowledge of GxP (Good Manufacturing/Laboratory/Documentation practices).
• Knowledge of FDA Validation and 21 CFR Part 11 a plus but not required.

The primary role of this position is to ensure IT business processes adhere to data integrity principles with effectiveness and efficiency. This position requires analysis of business processes – identifying gaps and remediation options – that will warrant robust processes governed by SOPs/ WKIs. The individual is required to collaborate with Global functions (R&D IT and Global Supply Chain) for an effective Data Integrity (DI) landscape.
The scope includes:
• Leading the Process Analysis, Process Documentation and SOP adherence across IT with support to the functions.
• Managing governance of processes, access, SOPs and documentation to ensure compliance.
• Representing IT on the Global Data Integrity Core Team for required regulatory activities.
• Aligning and managing the IT Compliance Training and Awareness program as per compliance initiatives.
The geographic scope is Global supporting all manufacturing & distribution sites – Melville (USA), Lachen/Oevel (Switzerland), Shanghai (China), Toronto (Canada), Seoul (South Korea), Tokyo (Japan), UK (Whitman) and EMEA.
1. Lead analysis of IT Data Integrity processes to ensure alignment with the overall Enterprise CyberSecurity & Risk corporate objectives
a. Analyze and document business processes.
b. Work closely with project managers and key program stakeholders to identify process gaps and remediation options.
c. Provide guidance on SOP/WKI templates and training to impacted departments to ensure their functional subject matter experts (SMEs) can create the required documentation.
d. Assist in managing and scheduling ECR’s training and awareness program(s).
e. Accurate record keeping for all training and training documentation on their respective learning management system.
f. Assist Global DI Lead and R&D Site DI Leads to conduct periodic verification of processes/SOPs/WKIs to ensure they are current and effective.
2. Collaborating with Corporate functions – Global Supply Chain, Global QA and IT – to ensure SOP and work Instruction standards are aligned cross-functionally.
3. Provide status updates (monthly/quarterly) at Site level to ensure visibility of process priorities and risks.
4. Work with Data Integrity IT resources and external vendors to ensure that data integrity controls are being properly maintained in Company’s central inventory system.