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Senior Manager/Manager, Clinical Quality Assurance -Peripheral Interventions (PI) Job

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Date: Jul 26, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

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

 

 

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.

 

About the role:

This is an exciting opportunity to create a Clinical Quality team for the Peripheral Interventions (PI) Division of Boston Scientific.  This Clinical Quality Assurance team will support ongoing PI clinical trials and the integration of BTG into the Boston Scientific Quality System. 

The Senior Manager/Manager is responsible for development of strategies and goals for PI to align with the global CQA management.  In additional, (s)he will ensure that the 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.

 

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 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.
  • 5-9+ years of related work experience in Clinical Quality with a strong understanding of audit processes.
  • Excellent communication skills
  • Up to 50% domestic and international travel to clinical sites for meetings and/or audits travel required

 

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.

 

Please note: This position may be filled at the Senior Manager or Manager level depending on the final candidate’s experience and expertise.

 

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: 449175

 


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