Overview:

Maintain a robust Quality Management (QM) program in concert with the Biologic Therapies Facility (BTF) Director, Director of Research and Development and Vice President of Research and Development. The QM Director will maintain compliance with provisions of FDA current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). In addition, the QM Director will coordinate quality agreements with internal and external sponsors of cell therapy and biologics development and manufacturing for experimental clinical trials. At minimum, this will include identification, monitoring and trending of critical quality metrics, audits, document control, process control, change control, facility and equipment control, personnel control, deviation control and records management. The QM Director is responsible for routine reporting to senior leadership and all required external regulatory and accreditation agencies. The incumbent will be expected to participate in creation of Drug Master Files (DMF), the Chemistry, Manufacturing and Control (CMC) module of Investigational New Drug (IND) applications to the FDA. The QM Director will be an active participant in strategic planning on operations of the BTF at BioRestorative Therapies. Responsibilities: · Extract quality metric data from batch process records and other records and analyze as quality monitors · Actively participate in design and implementation of master process records, review of resultant batch process records · Examine reports of deviations, non-conformances, complaints and adverse events, extrapolate critical information and apply to tracking and trending analysis · Create validation plans and evaluate success thereof · Communicate clearly, both verbally and in writing, staff assignments, quality reporting, resource requirements and utilization, problems and prospective solutions · Read and analyze reports, graphs, spreadsheets and other forms of data and integrate the information contained therein to facilitate performance of job functions · Day-to-day staff supervision of a dedicated group of cell therapy quality assurance team members Credentials and Experience: · Master’s degree in Science, Biology Quality or related field of study required. · 5 years work experience in a quality management capacity. · 5 years experience in production of biologic type pharmaceuticals, preferably cell or gene therapy products, including clinical lot release. · 5 years experience working with quality measure statistics and with relational databases such as Master Control. · Experience with product launches, health authority inspections, and global commercial product distribution requirements.· Proven ability to work in a fast-paced environment across multiple technical functions.· Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply.· Preferably one of the following ASQ Certifications: CMQ/OE Certified Manager of Quality/Organizational Excellence, CQA Certified Quality Auditor, CQE Certified Quality Engineer, CRE Certified Reliability Engineer, CSSBB Certified Six Sigma Black Belt. Strong knowledge of regulatory requirements for cell and gene therapy products, ISO-7 cleanroom, and clinical trials is preferred ( eg. FDA 21 CFR 211, 21 CFR 1271, FACT, AABB, ISO 14644, ICH).

Job Type: Full-time

Pay: $126,280.00 - $137,068.00 per year

Benefits:

• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Ability to Relocate:

• Melville, NY 11747: Relocate before starting work (Required)

Work Location: In person