Manager of Quality
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
- 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