Preclinical Quality Audit Manager
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
