at The Jackson Laboratory in Bar Harbor, Maine, United States
The Jackson Laboratory has an exciting new leadership opportunity on the Comparative Medicine & Quality team for a Director of Global Quality!
The Director of Global Quality will define and promote a quality mindset across the entire JMCRS ( JAX Mice & Clinical Research Services) operation to position The Jackson Laboratory as the world leader and standard setter in quality mice and services. This individual will be experienced in Good Laboratory Practices as well as non-GLP study practices.
The Director of Global Quality will lead a team of professionals ensuring the highest standard of Quality by managing regular internal audits of business and operational units, performing major CAPAs, leading process quality control and customer-initiated audits. This individual will establish and maintain a quality system to ensure JMCRS' facilities, equipment, personnel, methods and procedures conform to both internal guidelines and, as appropriate, regulatory standards.
This individual can be based out of either the Bar Harbor, ME or Sacramento, CA location. The Director of Global Quality can also be remote, with frequent travel to Maine and California.
* Assures quality mice, services and processes by establishing and enforcing quality standards and testing associated materials and products.
* Implements in-progress inspection/auditing standards for ongoing in-vivo studies, other services and production processes.
* Manages a quality systems software system.
* Creates product quality documentation system by writing and updating quality assurance procedures.
* Maintains product quality by enforcing quality assurance policies and procedures, and prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
* Manages quality assurance staff job results by coaching, counseling, and leading employees.
* Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
* Achieves financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
* Bachelor's degree in a related scientific field with 5-10+ years of Quality Assurance experience, ideally including all phases from clinical through commercial drug product; MS degree in life sciences preferred. Preferred Certification: Six Sigma Master Black Belt
* Minimum Experience Required: Five (5) years of quality management experience with global responsibility.
* Experience with MS Word, Excel, Project Management and Analytics Software and statistical packages.
* Deep experience with pharmaceutical industry quality management systems and quality system design.
* Experience working in a biotech with biologic, gene therapy or advanced cell therapy products.
* Knowledge of and commitment to the application of phase appropriate quality principles.
* Experience supporting and leading regulatory authority inspections
* Familiar with managing/working with third parties (CMO, CRO).
* Excellent interpersonal, negotiation, presentation, and communication skills.
* Strong organizational skills with attention to detail.
The Jackson Laboratory (JAX) is an independent, nonprofit biomedical research institution with more than 2,400 employees. Headquartered in Bar Harbor, Maine, it has a National Cancer Institute-designated Cancer Center in Augusta, Maine, a genomic medicine institute in Farmington, Connecticut, and facilities in Ellsworth, Maine, Sacramento, California, and Shanghai, China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.
JAX employees work in a collaborative, value-driven, and team-based environment where the focus is on advancing science and improving patients' lives. Researchers apply genetics to increase the understanding of human disease and advance treatments and cures for cancer, neurological and immune disorders, diabetes, aging, and heart disease. JAX was voted among the top 15 "Best Places to Work in Academia" in the United States in a poll conducted by The Scientist magazine!
The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.To view full details and how to apply, please login or create a Job Seeker account