Position Details

Type Not Specified

Experience senior

Exp. Years 7 - 9 years

Education Bachelor's degree (BA or BS) in management, business, or a related discipline

Category Project & Program Management

About this role

The Senior Project Manager, RAQA plans, monitors, and manages internal projects from initiation through completion. The role secures resources and applies formal project management processes and tools to control scope, budgets, timelines, risks, and change control, ensuring delivery on time and within budget in a highly regulated environment.

Key Responsibilities

Assemble project teams, assign responsibilities, identify resources, and develop schedules
Track and communicate project budgets including forecasting, variance tracking, and financial reporting
Lead identification, assessment, monitoring, and closure of project risks
Manage scope, schedule, and cost changes using verification techniques to keep the project plan updated
Measure project performance and communicate variances and corrective actions to stakeholders

Technical Overview

This role emphasizes compliance-ready project execution in a regulated setting, including knowledge of FDA regulations, EU regulatory requirements, and ISO standards (e.g., ISO 13485). It also includes budget forecasting, variance tracking, financial reporting, and structured risk and change management processes.

Ideal Candidate

The ideal candidate is a senior project manager with 7–9 years of project management experience in Procurement, Research & Development (R&D), or Operations. They have hands-on experience delivering projects in an FDA-regulated and/or highly regulated environment, with familiarity of EU regulatory requirements and ISO 13485, and strong budget forecasting/variance tracking skills.

Must-Have Skills

Bachelor's degree (BA or BS) in managementbusinessor a related discipline7 - 9 years demonstrated project management experience in at least one discipline (ProcurementResearch & Development (R&D)Operations)Experience working in an FDAregulated and/or highly regulated environmentfamiliarity with EU regulatory requirementsISO standards (e.g.ISO 13485)FDA regulationsProven ability to analyze and resolve complex process and/or system issues using independent judgment

Nice-to-Have Skills

PMP certification or equivalent (i.e. PRINCE2) desiredExcellent interpersonal communicationcollaborative teamwork and negotiation skillsAbility to build trusting relationships with mid -level managementDemonstrated experience in presenting to executives

Required Skills

project managementscopebudgetstimelinesriskschange controlproject team assemblyschedulesresource planningcustomer requirements documentationforecastingvariance trackingfinancial reportingFDA regulationsEU regulatory requirementsISO 13485corrective actionsproject performance measurement

Hard Skills

project managementproject initiation through successful completionscope managementbudget managementtimeline managementrisk managementchange controlchange control using appropriate verification techniquesforecastingvariance trackingfinancial reporting at the project levelFDA regulationsFDA-regulated environmentEU regulatory requirementsISO standardsISO 13485resource planningproject team assemblydeveloping schedulescustomer requirements documentationassumptions and constraints documentationexecutive communication and presentingcorrective actionsproject performance measurement

Soft Skills

communicating detailed project budgetsbuilding team cohesivenessleadinginfluencingtrainingmentoringmotivatingcollaborative teamworknegotiation skillsability to analyze and resolve complex process and/or system issues using independent judgmentability to build trusting relationships with mid-level management

Certifications

Preferred

PMPPRINCE2

Industry & Role

Industry Healthcare & Medical

Job Function Manage RAQA internal projects end-to-end with compliance-focused project management across scope, budget, schedule, risks, and change control.

Role Subtype Project Manager

Keywords for Your Resume

Senior Project Managerproject managementscopebudgetstimelinesriskschange controlproject teamschedulesresourceforecastingvariance trackingfinancial reportingcorrective actionsFDA regulationsFDA-regulated environmentEU regulatory requirementsISO standardsISO 13485ProcurementResearch & Development (R&D)OperationsPMPPRINCE2executivesproject performance

Deal Breakers

Bachelor's degree (BA or BS) in management, business, or a related discipline, 7 - 9 years demonstrated project management experience, Experience working in an FDAregulated and/or highly regulated environment, Familiarity with EU regulatory requirements and ISO standards (e.g., ISO 13485)

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