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