The Project Manager will lead cross-functional projects in life sciences, develop project plans, manage budgets, and ensure compliance with GxP and FDA regulations.
This is a remote position.
Pharmavise is seeking experienced Project Managers with backgrounds in life sciences consulting and regulated GxP environments to support current and future client initiatives. This is a pipeline/talent pool opportunity intended to identify professionals who can lead cross-functional projects within pharmaceutical, biotechnology, and medical device organizations.
Projects may include quality remediation, manufacturing operations, validation, engineering, digital transformation, clinical operations, regulatory compliance, product development, PMO support, inspection readiness, system implementations, and operational improvement initiatives.
The ideal candidate is highly organized, collaborative, client-facing, and experienced managing complex projects in FDA-regulated environments.
- Lead and manage cross-functional projects within pharmaceutical, biotechnology, and/or medical device environments
- Develop and maintain project plans, timelines, budgets, risk registers, and status reports
- Coordinate project activities across Quality, Regulatory, Engineering, Validation, Manufacturing, Clinical, and Supply Chain teams
- Facilitate stakeholder meetings and communicate project updates to client leadership and internal teams
- Identify project risks, issues, and mitigation strategies to ensure successful project execution
- Support project governance, resource planning, prioritization, and execution activities
- Ensure projects align with applicable GxP, FDA, ISO, and industry compliance requirements
- Drive accountability, action item tracking, and project deliverables across multiple stakeholders
- Support continuous improvement and operational excellence initiatives
- Maintain strong client relationships and represent Pharmavise professionally in client-facing environments
We are interested in Project Managers with experience supporting initiatives such as:
- FDA remediation and inspection readiness
- CAPA and Quality Systems projects
- Manufacturing site expansions or tech transfers
- Commissioning, Qualification, and Validation (CQV)
- Computer System Validation (CSV) / CSA projects
- Product development and design control initiatives
- Clinical operations and trial management
- ERP, QMS, MES, LIMS, or digital transformation implementations
- PMO and enterprise transformation programs
- Supplier quality and operational excellence projects
Required
- Bachelor’s degree in Engineering, Life Sciences, Business, Healthcare, or related field
- 5+ years of Project Management experience within the life sciences industry
- Experience supporting pharmaceutical, biotechnology, and/or medical device organizations
- Strong understanding of GxP-regulated environments
- Demonstrated experience managing cross-functional teams, timelines, budgets, and project deliverables
- Excellent communication, stakeholder management, and organizational skills
- Ability to work independently in fast-paced client environments
- Proficiency with project management and collaboration tools such as Microsoft Project, Smartsheet, Jira, SharePoint, or similar platforms
- PMP certification or equivalent project management certification
- Experience within consulting or professional services environments
- Experience supporting Fortune 500 life sciences companies
- Knowledge of FDA, ISO 13485, 21 CFR Part 11, ICH, GMP, GLP, or GCP requirements
- Experience leading global or multi-site projects
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