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Senior Clinical Quality Assurance Specialist (Remote Opportunity) Job

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Date: May 3, 2021

Location: Marlborough, MA, US, 01752

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 Clinical Quality Assurance Specialist-Peripheral Interventions

Location: Remote - US or Europe based

 

About the role:

The Senior CQA Specialist assists the Manager, Clinical QA, with internal quality assurance program for the assigned business area.  This includes clinical compliance, internal and external quality audits, Inspection Readiness program, and, supporting Clinical Corrective and Preventative Action (CAPA) and acquisition integration.

 

Key responsibilities include:

Clinical Compliance: Hands on partnership with PMs for inspection readiness

  • Participate on clinical project teams to foster and inspire clinical teams towards a state of inspection readiness at all times.
  • Provides support and response to compliance and regulation questions including quality review of clinical study documents
  • Supports Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections.
  • Coordinate/participate in BIMO sponsor inspection, and other regulatory agency sponsor inspections of BSC offices.
  • Preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
  • Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.

 

Independent Auditing

  • Plans, schedules, and conducts external clinical quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
  • Plans, schedules, and conducts internal clinical quality assurance process audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
  • Plans schedules and conducts clinical vendor assessments, qualification and periodic. Review, revise, update and maintain Clinical AVL
  • Documents audit observations; evaluates impact and makes recommendations for corrective actions. Evaluates responses to audit findings and ensures that appropriate corrective actions are completed.
  • Communicates observations to clinical investigators, clinical program managers, directors, and management
  • Contributes to the development of audit procedures and processes.
  • Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.

 

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements

  • Support Clinical and QS team during External Regulatory/Notified Body audits
  • Supports the CAPA program; assessing internal noncompliance recommending initiation of NCEPs, Clinical CAPA team member working cooperatively with NCEP/CAPA owners providing quality input.
  • Assists in acquisition integration by supporting the assigned Clinical Quality team member on clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements.
  • Supports clinical teams in gathering and reporting various performance metrics by assisting CQA manager in preparing slides and overall health statement for quarterly Management Review meetings.
  • Participates on clinical process improvement projects and initiatives.
  • Supports departmental, divisional, and corporate quality goals and priorities. 

 

What we're looking for in you:

Minimal qualifictions:

  • Bachelor’s degree and 3-5 years experience in medical device or phamaceutical industry in an area regulated by GCP requlations and guidelines; clinincal QA and/or compliance expereince
  • 3+ years direct clinical quality (GCP) auditing experience
  • Ability to communicate with all levels of the organization
  • Domestic and international travel up to 30-50%. 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 patients.

Preferred qualifications:

  • SoCRA or ACRP certification or equivalent
  • EU CA experience 

 

Requisition ID: 480066

 

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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