Clinical Quality Project Manager

Boston Scientific • Maple Grove, MN

6d

About The Position

Your responsibilities will include: Manage and deliver clinical quality projects and initiatives in support of clinical programs and organizational quality objectives. 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. Support internal and external audits and regulatory inspections, including preparation, participation, and follow-up actions. Facilitate cross-functional communication and alignment to resolve quality issues and support project goals. 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. 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.

Requirements

• 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.
• Bachelor's degree with a minimum of 3 years' professional experience that includes project management.
• Clinical quality experience.

Nice To Haves

• 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.

Responsibilities

• Manage and deliver clinical quality projects and initiatives in support of clinical programs and organizational quality objectives.
• 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.
• Support internal and external audits and regulatory inspections, including preparation, participation, and follow-up actions.
• Facilitate cross-functional communication and alignment to resolve quality issues and support project goals.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees