Lead Manager of Clinical Quality Assurance

1 week ago

Arden Hills, Minnesota, United States Boston Scientific Full time

Work mode: Hybrid

Onsite Location(s):

Various locations across the United States

Core Values: Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we empower you to unleash your potential by collaborating with a diverse team of high-achieving professionals, addressing critical challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we are committed to supporting your career development and skill enhancement. Here, you will find encouragement to pursue your aspirations.

Role Overview:

The Senior Manager of Clinical Quality Assurance is responsible for steering the Clinical Quality team within the Endoscopy and Urology divisions. This role involves formulating divisional strategies and objectives that align with the overarching goals of the global Clinical Quality Assurance management team. Furthermore, the manager will work closely with clinical trial teams to ensure that all clinical research activities adhere to federal and international regulations, as well as Boston Scientific's internal policies and standards.

This position offers a hybrid work environment and can be based at various campus locations.

Key Responsibilities:

  • Partner with Clinical leadership to foster and maintain a culture of quality.
  • Engage with Clinical leadership to identify needs and set priorities.
  • Collaborate with Global Clinical Quality teams to continuously seek improvement opportunities.
  • Serve as a subject matter expert in the interpretation and application of regulations.
  • Identify significant regulatory risks and propose solutions.
  • Develop strategies to enhance compliance with regulations and company policies.
  • Contribute to the creation, implementation, and upkeep of global quality systems.
  • Oversee the clinical audit program management.
  • Analyze audit results for trends and provide regular reports and recommendations to clinical leadership.
  • Supply data for management reviews and participate in those discussions.
  • Assist with internal and external audits to evaluate the accuracy and quality of scientific data and compliance with applicable regulations.
  • Review audit reports for precision and consistency.
  • Supervise Clinical Corrective and Preventive Action (CAPA) activities.
  • Review Standard Operating Procedures (SOPs) to ensure compliance with regulations and internal policies.
  • Provide input for training initiatives and deliver training on issues identified during audits.
  • Support the preparation and management of regulatory agency inspections, acting as the primary facilitator and communicator during inspections.
  • Prepare clinical sites for regulatory inspections and assist in drafting responses to findings.
  • Stay informed about regulatory requirements and update management on potential impacts of regulatory changes.
  • Lead a team of employees towards achieving organizational objectives, providing guidance, coaching, and development to direct reports.
  • Promote a diverse and inclusive workplace that allows all team members to contribute fully to organizational goals.
  • May oversee the activities and budget of one or more functional areas or projects.
  • Ensure adherence to company policies and procedures, including federal and regulatory requirements.

Required Qualifications:

  • Bachelor's degree with a minimum of 5 years of experience in Clinical Quality or a related field.
  • At least 5 years of direct or indirect management experience.
  • Expertise in FDA, ISO, and other relevant regulations related to Clinical Study activities.
  • Experience with audits and inspections.
  • Clinical site and vendor management experience.

Preferred Qualifications:

  • Proven proficiency in leadership and staff development.
  • Strong leadership skills, particularly in communication, collaboration, planning, innovation, and strategic thinking.
  • Advanced degree is a plus.

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