Project Manager
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
Qualifications
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
Preferred
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
Apply To This Job
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
Qualifications
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
Preferred
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
Apply To This Job