Project Manager – Quality Assurance & Regulatory Affairs

Cryoport, Inc.•Irvine, CA

About The Position

The Project Manager - Quality Assurance & Regulatory Affairs is responsible for managing Quality Assurance, Quality Unit, and Regulatory Affairs projects from inception through successful implementation of the identified outcome. This Project Manager - Quality Assurance & Regulatory Affairs will focus on driving multiple and complex projects, including identification, resource identification, design, project form/fit/deliverable, cadence, and projected timelines, if not provided by the organization or by direct supervision. This role may also lead Continuous Improvement and/or CAPA-related organizational initiatives, as required.

Requirements

Demonstrated excellent project management skills, with tenacity in stakeholder / participant communication and follow-up.
Capable of quantifying project deliverables into a clear and concise plan.
Excellent organizational and problem-solving skills.
Excellent communication skills; including interpersonal communication across all levels (team members, team leaders and executive management) and ability to tailor communications to the objective, stakeholder and project.
Electronic Quality Systems familiarity.
Strong decision-making, negotiating, and change management/change agent skills.
Knowledge and experience in the implementation of regulatory requirements.
Strong teamwork/collaboration and influencing skills at organizational levels below, on par or above.
Experience with schedule, budget, cost, resource, and risk management tracking tools.
Ability to facilitate meetings, including creating clear agendas and documenting meeting minutes.
Ability to make independent decisions (within established guidelines).
Strong working knowledge of commonly used project management software programs.
Minimum 7 years of experience in the life-science industry.
Bachelor’s degree in a technical or scientific discipline.

Nice To Haves

Advanced degree is a plus.
Experience in managing projects in FDA-regulated industry or comparable experience in other regulated environments, preferred.
Experience utilizing electronic Document Management / electronic Quality Management Systems tools preferred.

Responsibilities

Manage cross-functional, and interdisciplinary teams' projects in the execution of QA/RA initiatives and programs from initiation through project completion.
Engage in, and lead, discovery/scoping meetings with support from Quality & Regulatory Affairs, Operations, Engineering, and similar external-to-QA/RA stakeholders, to qualify projects and identify scope of work, budget, and timelines - including internal and external team scheduling and coordination - and capture sufficient information to create a formal project plan.
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.
Consistent application and use of acceptable project management methodologies to maintain accountability of all team members and timelines.
Develop Key Performance Indicators and project health metrics and maintain these metrics at the project basis; reporting at an organization level, if required.
Lead requirements gathering sessions with key stakeholders and ensure core requirements are captured to meet requirement(s) objectives.
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.
Manage and identify key resource needs across projects and across the organization to ensure project deliverables can be delivered on time and budget with existing resources (or identify the need for additional resources or key business leader commitment to have resources needed when required). Deliver regular reports on project successes, blockers and insufficiencies.
Quantify project deliverables and track progress, managing to prevent roadblocks rather than reacting to them.
Provide direct and accurate reporting of project deliverables and accountability with the mindset of assisting management in the coordination of resources.
Develop and maintain initial, monthly and quarterly project summaries, highlighting progress and any necessary mitigation options.
Conduct post project analysis to identify potential improvement in processes, ensure project goals were met, evaluate cost variances as applicable, analyze actual versus projected metrics, and determine the overall efficiency of the project.
Escalate threats to project plan as required to functional management and senior leadership.
Responsible for timely communication of project status updates, with mitigations to any gaps.