Quality Manager
Summary/Objective
The Quality Manager oversees all aspects of an organization’s quality management system or business improvement efforts, such as audits and inspections, CAPA, administrating document control, deviations as well as change control, training and coaching employees, suppliers, facilitating change throughout the organization, and equipment and assets control. Responsible for establishing strategic plans, policies, and procedures at all levels so quality improvement efforts will meet or exceed internal and external customers’ needs and expectations as part of the Operational Excellence business approach.
- Proficient in MS Office
- Database Management
- Project Management
- In-depth understanding of quality control procedures and relevant legal standards
- Excellent abilities and working knowledge of data analysis/statistical methods
Required & Desired Education and Qualifications
- Bachelor’s degree in chemistry is required.
- MBA or equivalent is not mandatory, but highly desired.
- A current Certified Manager of Quality (CMQ) or similar is required.
- Other Quality certifications can be beneficial.
- Lean Six Sigma, green belt experience is highly desired.
- 15 years of experience in Regulated Industry Quality Assurance and Quality Control is a must have.
- Specifically, 5 years of experience with QMS (21 CFR 210/211) / cGMP (ISO-22716) is required.
- Experience with LIMS (Laboratory Information Management System) is a plus.