At New York Blood Center, 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 Lead Auditor will develop and maintain a risk-based quality auditing program harmonized across all NYBCe sites. S/he monitors and evaluates NYBCe compliance with regulatory requirements, professional accreditation standards and internal policies and procedures to ensure the ongoing quality and safety of NYBCe products and services. S/he manages the quality audit program for NYBCe, including planning, risk assessment, scheduling, executing, and reporting on audits of the organization's facilities and operations. The Auditor also plans and executes audits of key suppliers and may coordinate or support audits of NYBCe by clients, regulatory agencies, and accrediting organizations. The lead auditor makes recommendations on areas of improvement based on audit observations and findings.

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 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.
  • Evaluates and approves audit responses.
  • Maintains documentation of audit activities.
  • Performs follow-up audits as indicated.
• 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.
• Assists in external inspection readiness activities and provide support during regulatory body inspections and customer audits.
• Liaisons with customers, suppliers and regulators as needed to coordinate and manage audit-related activities.
• Performs quality activities in support of NYBCe 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 NYBC policy.
  • Qualifies outside suppliers of reagents, materials and services used in critical processes according to NYBCe standards.
  • Participates in external regulatory and accreditation inspections, including preparation and follow up activities.
• 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.
• Compiles and reports key performance indicators and compliance status of Quality Audits and GMP Outsourced Activities to Senior Management.
• Authors Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
• Advises and trains QRA staff in quality auditing principles and techniques. Support the development and maintenance of a qualification program for Quality Auditors.
• Develops and conducts organizational training in regulatory and accreditation requirements and inspection readiness, as assigned.

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 five years' experience implementing, interpreting, and providing guidance on U.S. regulations for biologics, or providing quality assurance oversight in blood or biologics industry.
• Minimum three years' experience performing quality audits in a related, highly regulated environment, preferably in the blood, biologics or pharmaceutical industries.

Location Specific Details:

• Hybrid workplace with ability to travel up to 50% of time, locally or nationally.

Preferred Qualifications:

• ASQ 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.

Required Licenses / Certification:

• Valid driver's license with an acceptable driving record. (preferred)

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $110,000.00 p/yr to $120,000.00 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