Preclinical Quality Audit Manager

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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.           

About the role:

This position is responsible for leading the quality program for Boston Scientific’s Preclinical In Vivo and In Vitro Testing Laboratories in accordance with 21 CFR 58 Good Laboratory Practices, CFR Title 9 Animal Welfare Regulations, and Title 7 Animal Welfare Act. The role oversees the Preclinical Quality Assurance team, ensuring regulatory and internal compliance through quality assessments, audit readiness, and cross-functional coordination. It plays a key role in inspection readiness, CAPA management, and acquisition integration to drive continuous improvement and compliance across Boston Scientific's Preclinical operations.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Coordinate and manage quality programs to ensure that Preclinical In Vivo and In Vitro Testing Laboratories meet applicable external regulations and internal policies.
• Oversee quality system compliance by assessing BSC laboratories and suppliers against 21 CFR 58, Animal Welfare Regulations, and internal standards.
• Monitor laboratory activities, reviewing data and processes for GLP and animal welfare compliance.
• Lead process improvement initiatives and communicate quality trends and action plans to Quality and Laboratory Management.
• Interface with internal stakeholders to address quality system issues and verify implementation of corrective actions.
• Stay current on worldwide regulatory requirements impacting Preclinical Laboratories and advise leadership on necessary updates or process changes.
• Support Testing Laboratories during regulatory inspections or external audits (e.g., FDA, USDA).
• Lead the gathering and reporting of quality performance metrics for quarterly BU Management Review.
• Develop and manage a high-performing Preclinical QA team by providing training, mentorship, and performance management.
• Monitor daily team operations, provide direction and guidance to team members, and align efforts to project and departmental goals.
• Ensure the department’s work processes comply with Boston Scientific’s policies and contribute to ongoing quality system improvement initiatives.
• Identify resource requirements, manage staffing plans, and collaborate with HR on recruitment and selection processes.
• Develop and implement policies and procedures that improve the performance and consistency of the Preclinical Quality function.

Qualifications:

Required qualifications:

• Strong technical and quality knowledge of 21 CFR 58 GLP, CFR Title 9 Animal Welfare Regulations, and Title 7 Animal Welfare Act.
• Minimum of 5 years' experience in Preclinical GLP Quality Assurance or GLP Operations.
• Proven experience in project management and leading cross-functional teams.
• Strong verbal and written communication skills with the ability to interface effectively across levels and functions.

Preferred qualifications

• Minimum of 5 years' experience in the medical device industry or other regulated industries (e.g., pharmaceuticals, biologics, preclinical).
• Experience facilitating external audits with regulatory bodies such as the FDA and USDA.

Requisition ID: 623322 

Minimum Salary: $ 102100 

Maximum Salary: $ 194000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.