Boston Scientific · 13 hours ago
Clinical Quality Project Manager
US-MA-Marlborough
Full-time
Hybrid
Senior Level
7+ years expBoston Scientific is a leader in medical science committed to solving significant health industry challenges. The Clinical Quality Project Manager will assist in planning, coordinating, and executing clinical quality initiatives to ensure compliance with regulatory requirements and quality standards, while overseeing clinical research processes.
Health CareMedicalMedical Device
No H1B
Responsibilities
Manage and deliver clinical quality projects and initiatives in support of clinical programs and organizational quality objectives
Plan, track, and report on project timelines, deliverables, risks, and dependencies to ensure on-time execution
Partner with Clinical, Regulatory, and Quality stakeholders to ensure clinical activities comply with applicable regulations, standards, and internal procedures
Provide clinical quality oversight and guidance throughout study planning, execution, and close-out phases
Support implementation and maintenance of clinical quality systems, processes, and tools
Lead quality risk management activities, including identification, assessment, mitigation, and documentation of clinical risks
Support internal and external audits and regulatory inspections, including preparation, participation, and follow-up actions
Drive investigation, root cause analysis, and CAPA activities related to clinical quality issues and deviations
Monitor and analyze clinical quality metrics and trends; escalate issues and recommend continuous improvement actions
Review and contribute to clinical documentation to ensure quality, compliance, and consistency with internal standards
Facilitate cross-functional communication and alignment to resolve quality issues and support project goals
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
Qualification
Required
Minimum of a bachelor's degree, or an associate's degree with a minimum of 3 years' professional experience
Minimum of 3 years' experience in project management
Minimum of 7 years' experience in clinical quality assurance, clinical research, or a related field within the medical device or pharmaceutical industry
Experience working in FDA-regulated environments (medical devices, pharmaceuticals, or biologics)
Experience in either clinical or quality functions
Strong knowledge of GCP, ISO standards, and global regulatory requirements related to clinical research
Experience leading clinical quality projects and managing quality systems or initiatives
Willingness to travel up to 20% domestically and/or internationally
Strong knowledge of risk management processes and CAPA methodologies
Excellent interpersonal and communication skills with the ability to work cross-functionally
Ability to work independently and manage multiple priorities in a fast-paced environment
Preferred
Bachelor's degree with a minimum of 3 years' professional experience that includes project management
Clinical quality experience
Experience in pharmaceuticals and/or biologics in addition to medical devices
Experience working with CROs and clinical vendors
Prior experience supporting audits and regulatory inspections
Experience in a matrixed, global organization
Experience contributing to or reviewing clinical study documentation for quality and compliance
Benefits
Variable compensation governed by the Sales Incentive Compensation Plan
Core and optional benefits offered at BSC
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-22
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