Senior Regulatory and Audit Compliance Specialist-Quality Audit Exp Required
New York Blood Center
- New York City, NY
- $125,000 per year
- Permanent
- Full-time
- Protects the safety of patients and blood or HCT/P donors by notifying management and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services.
- Coordinate external inspections/audits by regulators, accrediting bodies, and customers. Provide guidance on regulatory issues to quality during the inspections, as needed. Collate and review responses to inspection findings and prepare final response report.
- Stay current on pertinent laws, regulations, rulings, interpretations, and decisions as they relate to NYBCe operations, and communicate to appropriate audience.
- Develops and conducts organizational training in regulatory and accreditation requirements and inspection readiness, as assigned.
- Prepare and submit regulatory registrations, license and permit renewals submissions, and amendments to support operations.
- Maintain records of regulatory communications and filings.
- Verify that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe policy.
- Support business clients with regulatory filings and strategies as outlined in Statements of Work (SOWs).
- Schedule, host, and/or support regulatory and client audits.
- Conduct and/or support internal audits.
- Conduct and/or support supplier audits for the NYBCe division for critical materials and outsource testing vendors.
- Contributes to process improvement efforts and leads team projects as needed.
- Identifies opportunities for improvement and makes recommendations based on monitoring and assessment activities.
- Assesses effectiveness of corrective action and preventive action plans.
- Leads or participates in formal process improvement team projects as assigned.
- Actively participates in regularly scheduled quality management system review meetings with operational staff and managers.
- Authors Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
- Track, trend, analyze and report on regulatory and performance data.
- Participates in Quality Improvement activities as assigned.
- Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, engineering, or quality management. Bachelor’s degree in another field of study may be considered with strong, relevant work experience.
- A minimum of 8 years of experience implementing, interpreting, and providing guidance on health authority regulations and regulatory applications for biologics is required.
- Experience performing and/or hosting quality audits and insepctions in a related, highly regulated environment, preferably in the blood, biologics or pharmaceutical industries.
- Position requires the ability to travel domestically up to 25% of time.
- American Society for Quality (ASQ) Certified Quality Auditor (CQA) or ISO Lead Auditor certification.
- Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.
- Understanding of the manufacture and testing of biologics and/or cellular and gene therapies is desirable.
- American Society for Quality (ASQ) Certified Quality Auditor (CQA) or ISO Lead Auditor certification.
- Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.
- Understanding of the manufacture and testing of biologics and/or cellular and gene therapies is desirable.