Sr. Director Quality Systems
$220,300–$352,500 year
On-site · San Diego, California, United States
Job Summary
Senior leadership role directing Medication Management Solutions (MMS) Quality Systems across multiple entities (including San Diego and Tijuana) to harmonize QMS and meet evolving regulatory demands. Drives design, development, and implementation of MMS QMS processes aligned with corporate goals; integrates MMS QMS into the broader BD QMS and Inspire Quality initiatives; leads or influences quality networks and capital resources; ensures efficient, compliant QMS operations and supports audits by regulators. Requires travel to engage MMS entities worldwide, with a focus on achieving compliance with standards such as FDA QSR, ISO-13485, EU MDR, and continuous improvement of CAPA, Change Control, Document Control, Post Market Surveillance, and Supplier Controls. Strong communication skills, leadership in a matrix environment, and ability to develop and execute a long-term QMS strategy.
Required Qualifications
- BS degree in a technical field
- Minimum 12-15 years of experience as a leader or senior leader of QA in a site/business unit with broad QMS responsibility or corporate-wide QMS in a global organization
- Willingness to travel worldwide to engage MMS entities
- Excellent verbal and written communication skills and ability to influence others
- Experience leading development, implementation, and continuous improvement of Quality Systems for medical devices (CAPA, Change Control, Document Control, Post Market Surveillance, Supplier Controls, Internal Audit)
- Strong leadership and matrix-management capabilities
- Knowledge of FDA QSR, ISO-13485, EU MDD/MDR; ability to develop long-term MMS QMS strategy
- CQE/CSQE/CQA/CQM certifications strongly preferred
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