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Clinical Quality Assurance Manager Job

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Date: Nov 24, 2021

Location: Maple Grove, MN, United States, 55311

Company: Boston Scientific

Additional Locations:


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.


Sr Manager Clinical Quality Assurance 

About the role:
Exciting opportunity to Lead Clinical Quality team, for the Peripheral Interventions Division of Boston Scientific.  This group supports ongoing clinical trials in both MD and Pharma Boston Scientific Quality Systems. Responsible for the management of the Clinical Quality Assurance team in line with strategies and goals set by global CQA management and the Divisional Goals.  Ensures clinical research activities conform to federal and international regulations and BSC procedures and expectations.


Your responsibilities include: 
⦁    Works with clinical senior management to gain acceptance of quality procedures.
⦁    Collaborates with Clinical management to understand needs and establish priorities.
⦁    Acquisition liaison – collaborates with clinical management to bring acquisitions into the BSC quality system. 
⦁    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.  Develops clinical audit procedures and processes.
⦁    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.
What we're looking for in you:
Basic Qualifications

⦁    Bachelor's degree in Science. Advanced degree preferred.
⦁    5+ years of related work experience in Clinical Quality with a strong understanding of audit processes. 
⦁    Excellent communication skills
⦁    Proven Experience in leading 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.
⦁    Occasional domestic and international travel to clinical sites for meetings and/or audits (less than 10%)

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: 505701


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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