What are the responsibilities and job description for the Manager, Medical Writing Quality position at GSMS, Incorporated?
Job Title:
Manager Quality Systems
About the Role:
The Manager Quality Systems will plan, coordinate, and direct the GSMS Quality Systems program to ensure continuous production of products consistent with U.S. regulatory requirements and GSMS policies and procedures.
Key Responsibilities:
- Investigations, CAPA, Change Control, Document Management, Specifications, Training, Product Complaints/Adverse Events, Recalls, Management Review, Annual Product Review, Inspection Management, as well as Quality System monitoring, trending, and reporting.
- Sure that 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.
Requirements:
- Bachelor's degree with a minimum 6 years of experience in pharmaceutical operations, or a High School Diploma with a minimum of 10 years of experience in pharmaceutical operations, and 4 years of Supervisory experience required.
- Strong knowledge of FDA GMP regulations and quality system regulations/requirements.
- Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control).
- Quality auditing experience.
- Strong data trending and analysis skills, with the ability to identify necessary remediation actions.
- Strong communication skills at all levels, both written and verbal; both individually and in a group setting.
Working Conditions:
Primarily sedentary position that requires long periods of desk work. Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas.
Equipment:
Standard office equipment, computers, full-body suit, goggles, cap, booties, gloves, and respirator.
