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Senior Manager, Clinical Quality Assurance (Remote optional) Job

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Date: May 4, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

 

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

 

Senior Manager, Clinical Quality Assurance

 

Location:  Remote optional or site based in any Boston Scientific campus

 

About the role:

This is an exciting opportunity to lead the Clinical Quality team for the Interventional Cardiology (IC) Division of Boston Scientific.  This Clinical Quality Assurance (CQA) team will support IC clinical trials across the division including Structural Heart, LAAC and Coronary Therapies.

The CQA Manager is responsible for development of strategies and goals for IC to align with the global CQA management. The CQA Manager will lead the team in partnership with the Clinical trial teams to ensure that the clinical research activities conform to federal and international regulations and BSC procedures and expectations.

 

Your responsibilities include:

  • Works with Clinical management to gain acceptance of quality procedures.
  • Collaborates with Clinical management to understand needs and establish priorities.
  • Acts as a consultant relative to the interpretation of regulations and their implementation.
  • Identifies key areas of regulatory risk and suggest potential 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 including, but not limited to, Site, Process and Vendor audits. 
  • Analyzes audit findings for trends and provides clinical management with regular reports.
  • 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.

 

Management requirements:

  • 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.
  • Foster 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).

 

What we're looking for:

Minimal qualifications:

  • Bachelor's degree in Science. Advanced degree preferred.
  • 7+ years of related work experience in Clinical Quality with a strong understanding of audit processes.
  • Clinical site and vendor management experience preferred
  • Ability to communicate with all levels of the organization
  • Domestic and international travel 30-50% expected. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patient.

Preferred qualifications:

  • Subject Matter Expert of FDA, ISO and other associated regulations pertaining to Clinical Study activity.
  • Demonstrated proficiency in staff leadership and development
  • Strong leadership competencies - particularly communication, collaboration, planning, innovation, and strategic thinking.

Requisition ID: 480124

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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