Digital Center of Excellence Project Manager

MDWerks Inc.

Project Manager overseeing enterprise systems implementations at biopharmaceutical company. Ensuring compliance and quality throughout SDLC in regulated environments.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $140,000 - $157,000 per yearWebsite

Tech Stack

Tools & technologies

Cyber SecuritySDLC

About the role

Key responsibilities & impact

Lead systems implementation projects across the full SDLC, including requirements definition, solution design, configuration, integration, testing, deployment, and transition to operations.
Develop and maintain integrated project plans, timelines, risks, and dependencies to support successful delivery and go‑live readiness.
Own execution quality, issue resolution, and progress tracking to ensure predictable, well‑managed outcomes.
Manage cross‑functional project teams spanning IT, Quality, business functions, and external vendors.
Partner closely with business and system owners to translate operational needs into clear system requirements and implementation plans.
Coordinate vendor delivery, ensuring alignment to scope, schedule, quality expectations, and Mineralys standards.
Ensure system implementations comply with applicable regulatory, data integrity, and electronic records requirements (e.g., GxP, SOX, 21 CFR Part 11), where applicable.
Coordinate Computer System Validation (CSV), SOX, or other compliance activities in partnership with system owners, business owners, and Quality.
Maintain appropriate project and system documentation to support audits and inspections.
Ensure projects align with established IT governance, architectural principles, cybersecurity requirements, and data management standards.
Support user adoption, training readiness, and operational handoff to ensure systems deliver sustained business value.
Contribute to the development and continuous improvement of IT project delivery practices, tools, and frameworks across the enterprise.

Requirements

What you’ll need

Bachelor’s degree required; advanced degree preferred.
Minimum of 3-5 years of IT project management experience, including enterprise software or SaaS implementations.
3+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated life sciences environments.
Demonstrated experience delivering systems subject to GxP, SOX, 21 CFR Part 11, or similar regulatory frameworks.
Strong working knowledge of SDLC practices for enterprise or SaaS system implementations.

Benefits

Comp & perks

medical
dental
vision
time off
401K

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SDLCsystem implementationproject managementComputer System Validation (CSV)regulatory compliancesolution designintegrationtestingdeploymentdata management

Soft Skills

leadershipcommunicationproblem-solvingcollaborationorganizational skillsissue resolutionprogress trackinguser adoption supporttraining readinesscontinuous improvement

Certifications

Bachelor’s degreeadvanced degree