Digital Center of Excellence Project Manager
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Job Description
Project Manager overseeing enterprise systems implementations at biopharmaceutical company. Ensuring compliance and quality throughout SDLC in regulated environments.
Responsibilities:
- 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:
- 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:
- medical
- dental
- vision
- time off
- 401K
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