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The VetStem Headquarters

Career Opportunities

Manager of Quality

Location

Poway, CA

Description

Manage the company Quality program to include Document Control, Supplier Qualification, Materials, Product Stability, Internal and External Auditing, CAPA, Complaint, Environmental Monitoring, OOT/OOS, NCMR, Training and Deviation programs. Company is both FDA GTP service laboratory and a fully GMP cell manufacturing facility

Requirements


- Bachelor’s degree in a scientific discipline (biology) and a minimum of 5-7+ years’ experience in GMP Quality Programs, preferably in cell therapy or biologics manufacturing environment
- Demonstrated experience in supervising and management with 5+ years’ experience in FDA regulatory environment
- Strong understanding of GMP, GLP & GCP requirements, including FDA/CBER/CVM procedures.
- Strong organizational, interpersonal, written and communication skills.
- Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines
- Experience working in a small company matrixed-reporting environment
- Demonstrated ability to effectively advocate a strategic quality systems approach and lead the organization in compliance
- Excellent communication, organizational, interpersonal and computer skills including Word, Excel, Access and Project Management Software
- Ability to identify compliance issues, communicate issues to others and identify resolutions effectively. Experience in developing and maintaining a quality management systems with a strong understanding of US and EU regulations
- Auditing experience in FDA/GMP manufacturing environments (ASQ certification preferred)
- Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies