Senior Manager Quality Assurance
3 weeks ago
This position is responsible for providing QA oversight of the Deviations, CAPA, and Complaints organization. The Senior Manager works closely with the Program Management team to facilitate communications between KBI and clients regarding quality-related events. The role will develop and maintain the Quality Assurance staff by recruiting, training, and managing team members.
Key Responsibilities:
- Functions as the system owner for the Deviation, CAPA, and Complaint Quality systems.
- Track, trend, compile, and report quality metrics as required.
- Provides compliant investigations and review and approve investigations and corrective/preventative actions as needed.
- Develop and/or support training materials for Quality Systems to include Deviation/CAPA system and batch record review.
- Provide training and certification of QA personnel.
- Provides coaching and mentoring to direct reports and QA specialists.
- Support Client Audits and Regulatory Inspections as required.
- Partners with Program Management, Technical Operations, and AFS, and Manufacturing to provide support.
- Communicates with clients, as needed, regarding quality-related events.
Requirements:
- Required Education: BS
- Required Experience: 10+ years experience in QA or cGMP environment
- Experience in providing QA support of Quality Systems to include Deviations, CAPAs, and Complaints
- 4+ Years of supervisory experience
- Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem-resolution skills.
- Strong understanding of FDA, EU, and ROW cGMP regulations is required.
Salary Expectation: $130,000K
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