Senior Manager of Quality Systems
1 week ago
We are seeking a highly skilled Senior Manager of Quality Systems to join our team at Charles River Laboratories. As a key member of our Quality Systems Organization, you will be responsible for partnering with global Quality stakeholders to develop, implement, and continuously improve our Quality Management Systems.
Key Responsibilities- Manage and oversee the continuous improvement of current Quality Systems as defined in the Quality Improvement Plan.
- Evaluate the Quality needs of incoming clients by assessing their Quality Systems and developing a plan to integrate their processes into our Quality Systems.
- Build cross-functional relationships with internal and external stakeholders to ensure sustained delivery of Quality System performance and KPIs.
- Support the selection and implementation of electronic Quality systems for use at our Memphis site and consistent application across our network.
- Maintain knowledge of policies and procedures concerning Quality Systems and operational philosophies.
- Lead and develop a team of Quality employees with varying levels of experience.
- Bachelor's degree in science or engineering.
- 5 or more years of experience in Quality, Manufacturing, Engineering, or a related field.
- Direct experience supporting customer audits or Regulatory inspections.
- Minimum 2 years of management experience in a manufacturing environment.
- Knowledge of current GxP regulations and QMS requirements, as well as current industry best practices in the area of biologics or cell and gene therapy manufacturing.
- Previous experience in the deployment, validation, and/or use of electronic Quality Systems for document control, deviation management, CAPA, and change control.
- Proficient in computer system use, including Microsoft Office Suite and QMS software.
- Strong analytical, problem-solving, and project management skills.
- Good leadership, interpersonal, communication, influencing, and negotiation skills.
Charles River Laboratories is a leading contract research organization (CRO) that provides a range of services to support the discovery and development of new medicines. With over 20,000 employees across 110 facilities in over 20 countries, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients' unique challenges.
We are passionate about our role in improving the quality of people's lives, and our mission, excellent science, and strong sense of purpose guide us in all that we do. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
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