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Clinical Quality Assurance Manager II Job

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Date: Mar 16, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minnetonka

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Clinical QA Manager II

 

About the role:

Responsible for the management of select Clinical Quality Assurance activities in corporate in line with strategies and goals set by Quality and Clinical management.  Ensures clinical research activities conform to federal and international regulations and BSC procedures and expectations.

 

Your responsibilities include

  • Responsible for the Product Approval – Clinical trial quality subprocess, including Quality steward roles and responsibilities.
  • Works with quality and clinical senior management to align on priorities for maintaining the Product Approval – Clinical trial quality system subprocesses, including process improvements, maintenance of procedures to regulatory requirements, and addressing non-compliance risks.
  • Acts as a consultant relative to the interpretation of regulations and their impact on Clinical trial processes, procedures and 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 in emerging markets (e.g. India, AMEA) in the absence of a dedicate regional clinical quality staff. 
  • Develops clinical audit procedures and processes.
  • Partners with divisional/regional clinical and clinical quality to analyzes audit findings for trends and identify opportunities for improvement.
  • Provides data for, and participates in, Executive Committee management review.
  • As needed, assist with internal and external audits as a Clinical SME to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
  • 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 strategist and Clinical Quality SME.
  • Keeps abreast of regulatory requirements, and updates management on the possible ramifications of regulatory changes.
  • Develops department plans and budgets, and monitors spending.
  • Recruits, trains, supports, and develops junior Clinical Quality Assurance staff (Auditors and Specialists).

 

What we’re looking for in you:

  • Bachelor’s degree in Life Sciences, Engineering, or related field
  • Minimum 8 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 5 years clinical QA experience; direct clinical quality (GCP) auditing experience preferred but not required.
  • Project Management or other business process improvement experience required
  • Travel up to 25% can be expected
  • Medical device experience desired

 

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 443520

 


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