Head of Quality and Regulatory Compliance
2 weeks ago
Position Summary:
As the Head of Quality and Regulatory Compliance at Enzo Biochem Inc., you will play a pivotal role in ensuring that our quality benchmarks are consistently achieved throughout the manufacturing process. You will be tasked with the development and management of the organization’s Quality Management System (QMS) along with related protocols, which encompass validation processes, supplier assessments, quality contracts, product submissions, and all necessary regulatory documentation, including registrations, licenses, and audits.
(This position offers a hybrid work model)
Key Responsibilities:- Drive the implementation and ongoing enhancement of the QMS and the Quality Assurance framework within the manufacturing sector.
- Guarantee that all products and services align with established quality standards and specifications.
- Lead and supervise successful audit processes, acting as the primary contact for all quality compliance audits and managing the resolution of any outstanding issues.
- Ensure adherence to policies and procedures that uphold the quality and compliance standards throughout product development and lifecycle management.
- Provide quality guidance and support to project teams, including investigations into complaints and management of design changes.
- Ensure that product design and development processes comply with relevant regulatory standards by offering proactive advice throughout all development phases, in accordance with 21 CFR 820 and ISO 13485.
- Collaborate with project teams to address Corrective and Preventive Action (CAPA) initiatives and customer complaints.
- Facilitate risk management activities in line with ISO 14971 standards.
- Oversee regulatory and quality compliance for manufacturing facilities, utilities, equipment, and validation of computer systems.
- Conduct and manage internal audits based on GXP standards for 21 CFR 820, ISO 9001, ISO 13485, ISO 17025, and ISO 14971, as well as lead vendor audits and CAPA processes.
- Manage all quality and compliance aspects of supplier engagements and ensure that GXP operations with contractors meet regulatory and company standards.
- Communicate and escalate vendor-related quality concerns within the organization.
- Lead investigations into significant quality and regulatory incidents involving external suppliers.
- Prepare manufacturing teams and related operations for regulatory inspections and certifications.
- Exhibit initiative, strong written and verbal communication skills, and innovative yet systematic thinking in managing quality assurance activities.
Education: Bachelor’s or Master’s degree in a scientific field.
Experience: A minimum of 10 years in Quality Assurance, Quality Control, Quality Systems, GMP Manufacturing, or Medical Device sectors.
Skills: Comprehensive understanding and application of GXP regulations, particularly 21 CFR 820, ISO 9001, ISO 13485, ISO 17025, and ISO 14971; experience engaging with FDA inspectors and other regulatory bodies; knowledge of root cause analysis and CAPA requirements; exceptional communication abilities.
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