Job Description

Additional Locations: (n/a)

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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

Sr GLP Auditor

About the role:

Assists with internal quality assurance program for preclinical GLP studies. Conducts internal and external GLP quality audits to assure that BSC preclinical trials comply with all applicable regulatory requirements, standards and BSC policies and procedures. Supports Inspection Readiness and Preclinical Corrective and Preventative Action (CAPA).

Your responsibilities include:

* Supports the preclinical study teams as the Preclinical Quality consultant.
* Conducts audits for assigned preclinical GLP studies and follows audits to closure.
* Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed.
* Provides support to GLP test site for audits by a Regulatory Authority/Competent Authority, as applicable.
* Provides support during a Regulatory Authority/ Competent Authority inspection of Boston Scientific preclinical processes and GLP studies.
* Supports the integration of preclinical processes of business acquisition and acquired preclinical GLP studies, as assigned.
* Supports internal process improvements, as assigned.
* Supports the CAPA process, working cooperatively with preclinical NCEP/CAPA owners.
* Supports preclinical teams in gathering and reporting various performance metrics
* Plans, schedules, and conducts preclinical vendor audits.

What were looking for in you:

Minimum Requirements

* Bachelors degree, preferably in medical device industry
* 5 years Preclinical QA experience; minimum 3 years direct Preclinical quality (GLP) auditing experience
* Ability to communicate with all levels of the organization
* 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.

Certifications/Licensures:
The following certifications are desirable:
- RQAP-GLP
- ISO17025 audit certification
- ASQ Quality Auditor

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 youre looking to truly make a difference to people both around the world and around the corner, theres 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

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.

Requisition ID: 474349