)
)
Q&RA Project Manager
The Project Manager will coordinate and drive Quality and Regulatory activities within a divestiture program, ensuring delivery against project timelines, regulatory requirements, and business priorities. The role will manage stakeholders, dependencies, risks, actions, decisions, and approvals, while coordinating readiness through cutover and post-close stabilization. The Project Manager will ensure that key activities and deliverables are clearly planned, tracked, communicated, and completed.
Key Responsibilities
Project & Workstream Management
Coordinate Quality and Regulatory workstreams across global, regional, and site stakeholders.
Manage timelines, milestones, dependencies, risks, issues, actions, decisions, and approvals.
Ensure key documentation, records, and completion evidence are appropriately maintained.
Identify delays, risks, and resource constraints and escalate as required.
Operational Readiness & Cutover
Coordinate readiness and cutover planning for Quality and Regulatory activities.
Track readiness criteria, deliverables, dependencies, and outstanding actions.
Support transition planning for processes, systems, records, roles, responsibilities, and governance.
Help ensure continuity of critical Quality and Regulatory activities through the transition and stabilization period.
Stakeholder Management & Reporting
Act as the central coordination point for Quality and Regulatory project activities.
Facilitate workstream meetings, readiness reviews, governance forums, and steering committee updates.
Prepare status reports, dashboards, leadership summaries, and escalation materials.
Follow up with accountable owners to ensure timely completion of actions and deliverables.
Minimum Requirements
Experience managing or coordinating cross-functional projects in a regulated environment.
Experience within Quality Assurance, Regulatory Affairs, within a life sciences environment.
- Experience working in a regulated life sciences, diagnostics, medical device, IVD, pharmaceutical, biotechnology, veterinary, or microbiology-related environment.
Good understanding of quality management systems and regulated product lifecycle requirements.
Strong organizational, stakeholder management, communication, and reporting skills.
Ability to manage multiple workstreams, priorities, and deadlines.
Power BI experience a plus.
Details
Latest start: September
Duration: 10 months
Scope: Full-time
Location: Remote
)