Regulatory Relations Specialist jobs in New Castle, DE

Overview

Founded in 1954, Blood Bank of Delmarva (BBD) is a non-profit, community-based blood center providing blood and blood products to hospitals in the Delmarva region. The Quality and Regulatory Affairs department is responsible for protecting the safety of the donors and patients we serve by ensuring that organizational policies, processes, and practices comply with quality system essentials and regulatory requirements of federal, state, local and industry focused agencies. The department also works with BBD leadership to promote a culture of quality and continuous process improvement. This position is a rewarding opportunity to have a hands-on role in ensuring a safe, effective blood supply for the patients in our community. BBD is FDA licensed, a member of America's Blood Centers, and accredited by AABB.

Responsibilities

The Regulatory and Audit Compliance Specialist (“Specialist”) is responsible for developing and maintaining a risk-based quality auditing program for the New York Blood Center Enterprise division. The Specialist monitors and evaluates divisional compliance with regulatory requirements, professional accreditation standards and internal policies and procedures to ensure the ongoing quality and safety of products and services.

Additionally, the Specialist is responsible for regulatory and accreditation activities related to cGxP manufacturing and clinical and laboratory services at the NYBCe division. These include, but are not limited to, activities regulated by the FDA (Food and Drug Administration), AABB (Association for the Advancement of Blood and Biotherapies), (FACT) Foundation for the Accreditation of Cellular Therapy, state departments of health, state laboratories, blood and tissue regulators, and CMS (Center for Medicare and Medicaid Services) / CLIA (Clinical Laboratory Improvement Act).

• Manages Audits: The Specialist manages the quality audit program for the division, including planning, risk assessment, scheduling, executing, and reporting on audits of the organization’s facilities and operations. The Specialist also plans and executes audits of key suppliers, external service providers, and transfusion service clients, and coordinates and manages external regulatory inspections and customer audits. The auditor makes recommendations on areas of improvement based on audit observations and findings.
• Advises on Compliance: The Specialist represents the division as a direct liaison to regulators, managing communications, Biologics License Applications (BLA) submissions, regulatory reporting, and ongoing compliance matters, including the filing of Biological Product Deviation Reports (BPDRs). The incumbent serves as a subject matter expert, advising divisional leadership of new or changed regulations and standards, and providing interpretation for successful implementation.
• 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.
• Monitors and evaluates NYBCe / division operational systems for quality and compliance with regulatory and accreditation requirements.
  • Performs risk assessments.
  • Develops annual audit schedule.
  • Prepares and communicates audit plans.
  • Leads audit teams.
  • Prepares written report of audit findings and communicates to auditee and quality business partners.
  • Evaluates and approves audit responses.
  • In conjunction with Quality Specialists, conducts effectiveness checks to ensure audit corrective actions have been made and are achieving the desired result.
  • Maintains documentation of audit activities.
  • Performs follow-up audits as indicated.
  • Performs “for cause” audits on an as-needed basis.
• 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.
• Liaisons with customers, suppliers and regulators as needed to coordinate and manage audit and compliance-related activities.
• Performs quality activities in support of NYBCe divisional program areas.
  • Verifies that products and services consistently meet defined specifications.
  • Ensures adequate CAPAs are developed in response to audit findings and monitors CAPA closures.
  • Confirms that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe / divisional policy.
  • Evaluates critical suppliers for suitability to provide the organization with materials and products of the highest quality and that meet all applicable regulatory and organizational requirements.
• 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.

Qualifications

Education:

Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Bachelor’s degree in another field of study may be considered with strong, relevant work experience.

Related Experience

Minimum three years’ experience performing quality audits in a related, highly regulated environment, preferably in the blood, biologics or pharmaceutical industries.

Experience implementing, interpreting, and providing guidance on U.S. regulations for biologics, or providing quality assurance oversight in blood or biologics industry is preferred.

Any combination of education and experience equivalent to the requirements listed above has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job equivalent to the job requirements above.

Preferred Qualifications:

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 blood, cellular and gene therapies is desirable.