Boston Scientific Senior Clinical Quality Assurance Manager 

United States, Massachusetts, Marlborough 

661805485

About the role:

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. Hybrid positions are required to be on-site a minimum of 3 days per week.

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 people 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:

• A passion for leadership and demonstrated experience in developing strong and engaged teams.
• Strong leadership competencies including communication, collaboration, planning, innovation, and strategic thinking.
• Advanced degree
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.