What are the responsibilities and job description for the Sr. Manager Quality Systems position at GSMS, Incorporated?
The Sr. Manager of 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 Stability
- Validation Program
- Supplier Quality Performance
- Product Complaints/Adverse Events
- Recalls
- Management Review
- Annual Product Review
- Internal Audits
- Inspection Management
- Quality System monitoring, trending, and reporting
Experience and Requirements:
- Bachelor's degree in a related field (pharmaceutical operations, medical device)
- Minimum 10 years of experience in pharmaceutical operations, medical device, or other related industry
- 5 years of managing experience
- Thorough knowledge of FDA GMP regulations and quality system regulations/requirements
- In-depth knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control)
- Quality auditing experience
- Excellent data trending and analysis skills, with the ability to identify necessary remediation actions
- Excellent communication skills at all levels, both written and verbal; both individually and in a group setting
- Excellent skills in analytical thinking and problem solving
- Ability to perform multiple tasks and ability to effectively manage conflict
- Ability to work in teams to obtain results
- Proactively identify issues and acting
- Excellent decision-making skills. Ability to make decisions with limited information
- Effectively manage change and comfortable changing direction and acting without complete information
- Excellent organizational and prioritization skills
