Project Manager
Summary
Leads cross-functional projects in pharma/biotech/medical-device firms, ensuring GxP compliance and coordinating teams across quality, regulatory, engineering, and manufacturing.
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.
Key Responsibilities
- 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
Preferred Project Backgrounds
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