Implementation Lead - Pharmaceutical GxP R&D Systems

Duration: 6 months
Compensation: $100-125/hr
Location: 100% REMOTE

We are seeking an experienced Implementation Leader to drive the technical execution and change management of a GxP-regulated R&D (Regulatory, Pharmacovigilance, Clinical Medical Affairs etc.) IT system implementations within our biotech organization. This role will ensure the successful planning, validation, and adoption of the implemented system while maintaining compliance with regulatory, quality, and business requirements. The ideal candidate will have a strong background in IT delivery, GxP R&D systems, and cross-functional leadership.

Responsibilities:

Technical Execution & Delivery

• Partner with the Project Manager to ensure identification of all technical tasks and proactively plan and drive execution.
• Define and document technical constraints, dependencies, risks, and issues, ensuring proactive mitigation and resolution.
• Lead cross-functional teams to ensure seamless integration, configuration, validation, and deployment of the system.
• Ensure alignment of IT system design with enterprise architecture, security, and compliance standards.
• Oversee vendor and external partner engagements, ensuring technical delivery meets business and regulatory needs.

Compliance & Validation Oversight

• Ensure the implementation meets GxP, 21 CFR Part 11, Annex 11, and data integrity requirements.
• Define and drive execution of Computer System Validation (CSV) activities in collaboration with Quality and Regulatory teams.
• Support audits and inspections by ensuring proper documentation, validation evidence, and compliance adherence.

Change Management & Business Engagement

• Develop and execute a change management strategy to ensure smooth user adoption and minimal business disruption.
• Engage with business stakeholders to ensure the implemented system meets operational, compliance, and user needs.
• Coordinate training, knowledge transfer, and post-go-live support strategies.

Risk & Issue Management

• Identify, track, and proactively mitigate risks associated with technical execution, compliance, and business continuity.
• Work closely with the Project Manager and leadership to ensure timely resolution of technical and operational issues.
• Communicate progress, challenges, and key decisions effectively to senior leadership and stakeholders.

Requirements:

• 10 years of experience in IT project delivery, GxP system implementation, and R&D (Regulatory, Pharmacovigilance, Clinical Medical Affairs etc.) technology within biotech, pharma, or life sciences.
• Strong expertise in GxP, CSV, 21 CFR Part 11, and regulatory compliance requirements.
• Proven ability to plan, drive, and execute technical deliverables in complex system upgrades or implementations.
• Experience in cross-functional collaboration between IT, Quality, Regulatory, and Business teams.
• Strong understanding of technical dependencies, constraints, risk management, and execution planning.
• Experience in vendor management, contract negotiations, and SLA management.
• Knowledge of Agile, Waterfall, or hybrid project methodologies.
• Excellent leadership, communication, and stakeholder management skills.