Job ID | 2024-5777 | Category | Quality | Minimum Rate | USD $125,000.00/Yr. | Maximum Rate | USD $135,000.00/Yr. | Work Location Type | Physical |
At New York Blood Center Enterprises (NYBCe), one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.
The Senior Regulatory and Audit Compliance Specialist (Specialist) is responsible for regulatory and accreditation activities related to cGxP manufacturing at New York Blood Center Enterprises (NYBCe). These include, but are not limited to, the FDA (Food and Drug Administration), state departments of health, state laboratories, blood and tissue regulators, Foundation for the Accreditation of Cellular Therapy (FACT) and CMS (Center for Medicare and Medicaid Services) / CLIA (Clinical Laboratory Improvement Act). This position may be required to support similar accreditation activities for non-US regulatory bodies, such as, but not limited to, EMA, PMDA, MFDS, and ANVISA.
This position is also responsible to author, assess, and/or maintain regulatory filings, including, but not limited to the Chemistry, Manufacturing, and Controls (CMC) section of Investigational New Drugs Applications (IND) and Biologics License Applications (BLA) and/or international equivalents for NYBCe.
They represent the department as a direct liaison to regulators, managing communications, licensing submissions, and ongoing compliance matters, including coordination of the filing of Biological Product Deviation Reports (BPDRs).
The incumbent serves as subject matter expert, advising divisional leadership of new or changed regulations and standards, and providing interpretation for successful implementation.
Additionally, this role will support the divisional audit programs. They will coordinate and manage regulatory inspections and client audits throughout NYBCe sites. They will also conduct internal and external audits as needed in accordance with a risk-based quality auditing program for the NYBCe division. They will monitor and evaluate divisional compliance with regulatory requirements, professional accreditation standards and internal policies and procedures to ensure the ongoing quality and safety of NYBCe products and services. The auditor also plans and executes audits of key suppliers and external service providers. The auditor makes recommendations on areas of improvement based on audit observations and findings.
Education:
Related Experience:
Location Specific Details
License & Ceritfications:
Preferred Qualifications:
For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $125,00.00 p/yr to $135,000.00 p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant's skills, job-related knowledge, and experience.
Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.