Director, Quality Assurance
The New York Stem Cell Foundation (NYSCF) is a rapidly growing and highly successful nonprofit whose mission is to accelerate cures through stem cell research. We are a vibrant organization that advances cutting-edge stem cell research in our own laboratory and through the support of talented scientists at other institutions.
NYSCF is bringing this cutting-edge stem cell research directly into the clinic. The NYSCF team is seeking a Director of Quality Assurance as a key participant in this effort. This position is responsible for leadership and strategic direction and oversight of the Quality Assurance, Quality Control and Validation functions, under the supervision of the Senior VP Scientific Operations.
The Director of Quality Assurance is a full time position, located at the NYSCF Research Institute in New York, NY.
- Provide leadership, strategic direction, and assures accountability for Quality Assurance, Quality Control and Validation.
- Responsible for the safety, quality, and efficacy of all finished products manufactured at NYSCF.
- Develop and deploy a Quality System suitable for Cell Therapy products, including standards, methods and procedures for inspecting, testing and evaluating the safety, identity, strength, purity and quality of raw materials of various cell therapy and combination products. Systems to include policies, SOPs, CAPA, OOS, etc, validation processes, etc.
- Lead the annual quality review meeting to assess the Quality System for effectiveness.
- Generate, review and approve documents used in current Good Manufacturing Practices.
- Assure finished products conform to regulatory and company standards and satisfy GTP/cGMP/GLP/cGCP regulations and in a timely manner.
- Responsible for GTP/GMP/GLP compliance with applicable regulatory requirements by conducting audits, implementing training programs, performing data and documentation reviews and analysis. Make recommendations for corrective actions necessary to assure conformity with quality specifications and standards.
- Working with the head of Regulatory Affairs, prepare documentation for updated filings with the regulatory agencies.
- Provide Quality Assurance and compliance oversight for GMP supply chain, including supporting site identification and site qualification, audits of vendors, suppliers and contract manufacturers and creation of Quality Assurance Agreements (QAA).
- Responsible for the Document Control function and management of QA Controlled documents including implementation of future electronic document management system.
- Review/Approve all investigations.
- Lead regulatory inspections.
- Maintain current knowledge of applicable regulatory guidance and regulations.
- Assure quality compliance to current regulations and guidance.
- Coaching, mentoring and developing a Quality Assurance perspective among NYSCF staff.
- Perform vendor/contractor audits, as needed.
- Support software validation, as needed.
- Approve quality control specifications for finished product.
- Review/Approval of change controls for processes, tests, facilities, equipment, and software to evaluate the impact to validated systems.
- Participate in risk evaluation and mitigation for clinical development programs.
- Support GLP studies through test site qualification audits, protocol and report reviews.
- Review regulatory submissions.
- Author and negotiate quality agreements with suppliers/OEM partners.
- Analyze quality data for trends.
- Manage the Quality department budget.
- Other duties as assigned.
- Bachelor of Science in Biology or related field.
- 15+ years' pharmaceutical/biotech device industry experience; Cell Therapy/Regenerative Medicine experience preferred.
- 7+ years' direct Quality Assurance experience, ideally with combination products containing a biologic or drug (experience with biologics highly desired).
- Strong knowledge of cGMP regulations Experience with electronic document systems i.e., Trackwise, MasterControl, etc.
- Experience with aseptic processing.
- Working knowledge of 21CFR Part 58.
- In-depth knowledge of sections of the Code of Federal Regulations that apply to cell therapeutics, HCT/Ps, and gene therapeutics (21 CFR 210/211, 600/610, and 1271) in addition to related guidance documents.
- Ability to identify, define, and solve problems; trouble-shoot, lead, and influence and inspire.
- Excellent written and oral communication skills.
- Excellent project management abilities.
- Expertise using MS WORD and some statistical analysis software.
- Ability to travel for audits, etc.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.