About the role:

This role is seeking an experienced Project Manager to lead the successful deployment of GenAI-enabled automations and digital solutions across Global Quality Assurance (QA) and Regulatory Affairs (RA). This role will oversee global AI software system implementations spanning multiple Quality System and Regulatory subprocesses, supporting the organization’s digital transformation and efficiency goals.

The Project Manager will work closely with Business Analysts, AI Developers, Data Scientists, Quality Systems teams, AI governance leads, and global QA/RA stakeholders to evaluate, design, build, validate, and implement AI-enabled solutions. This individual will drive execution across multiple parallel workstreams, ensure alignment with software validation and lifecycle requirements, and deliver solutions that meet business, regulatory, and quality system expectations.

Locations: Boston, MA or Minneapolis/St. Paul, MN

Responsibilities will include:

• Manage all phases of the project lifecycle, including initiating, planning, executing, controlling, and closing processes.
• Develop and implement comprehensive project plans and foster team ownership and accountability for deliverables.
• Estimate project effort and resources needs using standardized tools and techniques in collaboration with relevant stakeholders.
• Prepare detailed schedules, budgets, and timelines using project management tools such as Microsoft Project.
• Direct project execution through task assignments, timeline tracking, risk identification, and contingency planning.
• Coordinate cross-functional alignment with Quality, Regulatory, Data Science, IT, Legal, and global site teams to ensure smooth delivery and adoption of AI solutions.
• Identify and manage project dependencies and critical path elements while maintaining high project quality using methodologies such as GSM.
• Communicate project status regularly through standard reports and executive-level updates.

Qualifications:

Required:

• Bachelor’s degree from an accredited institution.
• Minimum of 5 years' experience coordinating and/or leading software validation projects or IT/technology-related projects in a regulated environment.
• Professional experience in the pharmaceutical and/or medical device industry.
• Demonstrated knowledge of change management methodologies and their application in project environments.
• Proven experience collaborating with multiple internal stakeholder groups, including site, division, and regional Quality and Regulatory teams.
• Ability to work effectively with individuals at all organizational levels and with external vendors or consultants.
• Ability to meet project deliverables and performance expectations in fast-paced or evolving environments.
• Ability to work independently and assume responsibility for assigned project outcomes.

Preferred:

• BS degree in Engineering or IT.
• PMP Certification.
• Understanding of software validation/CSV principles.