Senior Clinical Quality Assurance Manager

1 month ago

Arden Hills, United States Boston Scientific Full time

Work mode: Hybrid

Onsite Location(s):

Marlborough, MA, US, 01752

Additional Location(s): US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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:

The Senior Clinical Quality Assurance Manager leads the Clinical Quality team for the Endoscopy and Urology divisions. They develop divisional strategies and goals aligned with the global CQA management team. Additionally, they collaborate with clinical trial teams to ensure clinical research activities comply with federal and international regulations as well as Boston Scientific procedures and expectations.

This is a hybrid position and can be located on one of the following campus sites: Marlborough, MA; Spencer, IN; Arden Hills, MN or Maple Grove, MN.

Key responsibilities include:

  • Collaborates with Clinical leadership in embedding and sustaining a culture of quality.
  • Collaborates with Clinical leadership to understand needs and establish priorities.
  • Collaborates with Global Clinical Quality teams to continually identify opportunities for improvement.
  • Acts as a subject matter expert relative to the interpretation of regulations and their implementation.
  • Identifies key areas of regulatory risk and resolutions.
  • Identifies ways to improve compliance with regulations and BSC policies and procedures.
  • Participates in the development, implementation, and maintenance of global quality systems.
  • Oversees management of the clinical audit program
  • Analyzes audit findings for trends and provides clinical leadership with regular reports and recommendations.
  • Provides data for, and participates in, management review.
  • As needed, assist with internal and external audits (internal systems, trial master file, investigator sites, clinical service providers) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
  • Reviews audit reports for accuracy and consistency.
  • Provides oversite of Clinical CAPA activity
  • Reviews SOPs to assure compliance with regulations and BSC policies and procedures.
  • Provides input to training function and, where appropriate, gives training on issues identified during audits.
  • Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices. During inspection, plays lead role as facilitator and communicator.
  • Prepares investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
  • Keeps abreast of regulatory requirements, and updates management on the possible ramifications of regulatory changes.
  • Will lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports (auditors and analysts), and drive those practices throughout their organization.
  • Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).


Required qualifications:

  • Bachelor's degree and 5+ years of Clinical Quality or related experience
  • 5+ years of direct or indirect management experience
  • Subject Matter Expert of FDA, ISO and other associated regulations pertaining to Clinical Study activity.
  • Experience working with audits & inspections
  • Clinical site and vendor management experience


Preferred qualifications:

  • Demonstrated proficiency in staff leadership and development.
  • Strong leadership competencies - particularly communication, collaboration, planning, innovation, and strategic thinking.
  • Advanced degree

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