Manager Quality Systems
The Manager Quality Systems will plan, coordinate, and direct the client’s Quality Systems program to ensure continuous production of products consistent with U.S. regulatory requirements and policies and procedures. Responsibility includes Investigations, Change Control, Document Management, Training, Supplier Quality, Product Complaints/Adverse Events, Recalls, as well as Quality System monitoring, trending and reporting.
Job Description (including but not limited to the following):
- Ensures quality system processes and activities are designed and performed in adherence to FDA cGMP’s.
- Formulates and maintains Quality objectives and coordinates objectives with other operations departments to maximize product quality and reliability and to minimize costs.
- Reports on key quality indicators to upper management.
- Supervises, directly and indirectly, quality systems staff. Performs goal setting and performance reviews per the client’s policies.
- Conducts training of personnel as necessary. Drives a culture of continuous improvement.
- Responsible for the design, execution, monitoring and improvement of the Quality Management System.
- Leads the development, monitoring and improvement of the Quality Management System metrics and reporting processes. Manages and executes the Quality Management System Review process.
- Responsible for the investigation program, including non-conforming events and deviations, Corrective Action/Preventive Action program and product stability program. Generates and/or approves stability reports as necessary.
- Also responsible for Change control process for product, process, equipment, facility and procedural changes, the client’s GMP Training Program and Product Complaints, Adverse Events, Product Recalls and Product Returns programs and processes.
- Accountable for supplier quality management.
- Internal and external audit programs, as well as regulatory and 3rd party inspections.
- Vendor, manufacturer, and internal audits.
- Supports regulatory and 3rd party inspections and inspection responses.
- Quality and compliance-related duties as assigned.
Skills and Requirements:
- Required working knowledge of basic Microsoft Office applications. More advanced knowledge of data analysis software and reporting (e.g., Excel, etc.).
- Strong internet research skills are required.
- Bachelor’s degree with a minimum 4 years of experience in pharmaceutical operations, or a High School Diploma with a minimum of 8 years of same experience, and 2 – 4 years of Supervisory experience required.
This position is located in the Camarillo area. Please call our offices for additional information.
Royal Staffing Services will consider for employment qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.