Cryoport

Project Manager – Quality Assurance & Regulatory Affairs

Irvine, California, USA · Senior

Sponsorship not specifiedDetected 62 days ago

ExpressProject ManagementSupply ChainLogisticsCustomer SupportCadenceFDA RegulatoryCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

Creation and active management of comprehensive, accurate and multi-stakeholder project plans which align to QA/RA standards (worldwide).
Schedule and scope activities for QA/RA projects supporting the strategic initiatives for the organization.
Quantify project deliverables and track progress, managing to prevent roadblocks rather than reacting to them.

Manage cross-functional, and interdisciplinary teams' projects in the execution of QA/RA initiatives and programs from initiation through project completion.
Consistent application and use of acceptable project management methodologies to maintain accountability of all team members and timelines.
Identify major milestones and delivery dates, manage project scope, track progress to detailed schedules including identifying critical path, constraints, contingencies, and mitigations to achieve project objectives.
Deliver regular reports on project successes, blockers and insufficiencies.
Develop and maintain initial, monthly and quarterly project summaries, highlighting progress and any necessary mitigation options.

Minimum 7 years of experience in the life-science industry.
Escalate threats to project plan as required to functional management and senior leadership.
This role may also lead Continuous Improvement and/or CAPA-related organizational initiatives, as required.
including interpersonal communication across all levels (team members, team leaders and executive management) and ability to tailor communications to the objective, stakeholder and project.
Experience with schedule, budget, cost, resource, and risk management tracking tools.
Ability to facilitate meetings, including creating clear agendas and documenting meeting minutes.

Bachelor's degree in a technical or scientific discipline.
Advanced degree is a plus.
Experience in managing projects in FDA-regulated industry or comparable experience in other regulated environments, preferred.

Demonstrated excellent project management skills, with tenacity in stakeholder / participant communication and follow-up.
Excellent organizational and problem-solving skills.
Strong decision-making, negotiating, and change management/change agent skills.
Strong teamwork/collaboration and influencing skills at organizational levels below, on par or above.

Develop Key Performance Indicators and project health metrics and maintain these metrics at the project basis; reporting at an organization level, if required.

This listing is sourced directly from Cryoport's careers page and normalized into a canonical job model.