Overview
Job title: Senior Quality Manager
I am currently partnered exclusively with a Personal Care contract manufacturer. We are in search for a Senior Quality Manager.
The Senior 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, 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 15 years of experience in Regulated Industry Quality Assurance and Quality Control is a must have.
- Specifically, 5 year experience with QMS (21 CFR 210/211) / , cGMP (ISO-22716) is a required.
- Bachelor’s degree in chemistry is required.
- MBA or equivalent is not mandatory, but highly desired.
- 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.
- Experience with LIMS (Laboratory Information Management System) is a plus.
Responsibilities
- Ensure that the organization’s Quality Management System conforms to customer, internal, cGMP, ISO 9001, FDA and regulatory/legal requirements.
- Ensure evaluation of, and reporting on, vendor quality systems.
- Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
- Oversee Quality Lab Testing, Quality Assurance, Quality Control, Validation as well as Document Control.
- Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products.
- Lead a team of Quality engineers, inspectors, auditors, analysts, and technicians.
- Work with customers, employees, contractors, and outsourcing firms to develop product requirements.
- Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
- Conduct periodic management review meetings.
- Oversee product recalls.
- Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.
- Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality.
Technical Skills
- 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
Soft Skills
- Consultation
- Critical Evaluation
- Relationship Management
- Organizational
- Strong Analytical and Problem solving skills
- Knowledge of Emerging Technologies
This role plays a critical part in maintaining high product quality and supporting continuous improvement initiatives within the organization.
Seniority level
Employment type
Job function
Industries
- Personal Care Product Manufacturing, Retail Health and Personal Care Products, and Personal and Laundry Services