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Director, Clinical and Pre-Clinical Quality Job

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Date: Dec 6, 2018

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills

 

 

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.

 

Director, Quality Systems

About the role:

The Director Corporate Clinical Quality and Pre-Clinical Quality is responsible for the Corporate Clinical Quality Assurance and Pre-Clinical Quality Assurance organizations, reporting to the VP of Quality Systems. The role ensures planning, coordination, control and continuous improvement of processes and methods are established to control the quality of studies conducted at, and on behalf of Boston Scientific. Lead a team focusing on continuous improvement projects using approved tools and ensuring adherence to regulations, GxP, Industry Guidelines, along with clinical policies and procedures for the conduct of clinical trials. 

 

Your responsibilities include:

  • The Director Corporate Clinical Quality and Pre-Clinical Quality plays a key leadership role in driving the BSC Quality Culture.
  • He/she will be committed to developing people and is recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in his/her everyday leadership style.
  • He/she will continuously foster and drive a continuous improvement approach to Quality ensuring that quality is the responsibility of everyone - not just the QA department and that the Quality System is an integrated and integral aspect of monitoring performance
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  • Responsibility for ensure compliance of the Boston Scientific Clinical and Pre-Clinical quality processes and procedures to all applicable regulatory requirements – including ICH GCP Principals, 21 CFR Parts 11, 50, 56, 58, 812, 820, 210, 211, ISO 13485, ISO 14155, TGA, cFDA and other international requirements as applicable
  • Global Quality System Steward for Clinical and Pre-Clinical
  • Drive development of goals and metrics that accurately and cost effectively focus improvements in quality performances.     
  • Responsibility for the establishment of implementation plans for External Regulation changes which impact the Boston Scientific Quality System – example: EUMDR, GDPR, MDSAP
  • Key leadership role in both regulation advocacy and resulting implementation strategies
  • Key leadership role in representing BSC interests externally
  • Participate in Global Clinical Leadership forums
  • Member of the Quality Systems Governance Board.
  • Key leadership role in partnering with Clinical and Pre-Clinical Organizations
  • Support Regional Quality System plans

     

    What we’re looking for in you:

  • Bachelor’s degree in a technical field
  • Minimum 12 years’ experience in the medical device or pharmaceutical industry with 10 years’ of related clinical experience in a similar environment
  • Experience in in GLP facility management will be of benefit, with direct responsibility for QAU.
  • Deep knowledge of clinical & pre-clinical processes and procedures, US, EU and International Regulatory Standards and GxP Guidelines for the conduct of Clinical Trials
  • Demonstrates initiative and proactively provides collaborative support to clinical team
  • Demonstrated effectiveness in maintaining CQA control systems for compliance with FDA and International regulations.
  • Experience in leading sites/organizations through FDA, Notified Body and other International Reg Agency Audits
  • Strong knowledge of appropriate state, Federal and international regulations impacting the company
  • Attention to detail and accuracy – essential
  • Ability to work well under deadlines and pressure
  • Problem Solving Skills essential
  • Excellent Analytical Ability
  • Ability to communicate clearly, accurately and directly – both verbally and in writing – to a widely varied audience.
  • Good business acumen
  • Proven history in managing diverse teams.
  • Experience in working collaboratively with industry and regulatory partners is essential
  • Minimum Travel – 25%

 

 

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: 437599

 


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