Director of Quality and Regulatory Assurance

1 month ago

Farmingdale, United States Enzo Biochem Inc. Full time
Job DescriptionJob Description

Job Description:

In the role as the Director of Quality and Regulatory Assurance, you will ensure that quality standards are met throughout the production process. You are responsible for the establishment and oversight of the company’s Quality Management System and associated procedures, including, but not limited to, validation protocols, supplier qualification, quality agreements, product submissions and associated regulatory documentation, registrations, licenses, certificates and audits.

(This is a hybrid position)

Responsibilities:
  • Implementation and continuous improvement of the company's Quality Management System, Manufacturing's Quality Assurance program and policies.
  • Ensure that products and services meet required quality standards and specifications.
  • Guide and oversee successful audits. Act as lead for all quality compliance-related audits and handle any follow-up/closing of outstanding items.
  • Ensure policies and procedures for assuring that the quality and compliance requirements of the company are being followed during product development and lifecycle management.
  • Provide Quality support and direction to project teams, complaint investigations and/or design change management.
  • Ensure device design and development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development in accordance with 21 CFR 820 and ISO 13485.
  • Partner with project teams, as required, in the resolution of Corrective and Preventive Action (CAPA) and complaints.
  • Ensure risk management activities are developed in accordance with ISO 14971 procedures.
  • Provide regulatory and quality oversight of Manufacturing facilities, utilities, equipment, computer system validations and change controls.
  • Manage and perform internal audits against GXP standards for 21 CFR 820, ISO 9001, ISO 13485, ISO 17025 and ISO 14971, lead vendor audits and CAPA approvals.
  • Responsible for managing all Quality and Compliance aspects of supplier activities and oversee GXP work placed with the contractor to ensure consistency and compliance with regulatory expectations and company standards.
  • Responsible for communication and escalation of vendor-related quality issues within the company.
  • Lead and support investigations of critical quality and regulatory events for external suppliers.
  • Prepare manufacturing personnel and all manufacturing related operations for regulatory inspections and certifications.
  • Demonstrate initiative, excellent written and verbal communication skills, and creative, yet process driven, thinking in addressing quality management activities.


Requirements:

Education: BS or MS in scientific discipline

Experience: 10+ years experience working in a QA, QC, QS, GMP Manufacturing or Medical Device role

Skills: Thorough understanding and application of GXP, specifically 21CFR820, ISO 9001, ISO 13485, ISO17025 and the principles and concepts of relevant quality processes and systems; Experience interacting with FDA investigators and other regulatory agencies' audits; Knowledge and application of device root cause analysis methodology and device CAPA requirements; Strong communication skills

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