Global Project Manager: Quality Systems AI Implementation
About the position
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Boston Scientific 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. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Responsibilities
• 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 resource 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 assignment, 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.
Requirements
• 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.
Nice-to-haves
• BS degree in Engineering or IT.
• PMP Certification.
• Understanding of software validation/CSV principles.
Apply tot his job
Apply To this Job
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Boston Scientific 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. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Responsibilities
• 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 resource 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 assignment, 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.
Requirements
• 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.
Nice-to-haves
• BS degree in Engineering or IT.
• PMP Certification.
• Understanding of software validation/CSV principles.
Apply tot his job
Apply To this Job