Lead Quality Systems Engineer

1 week ago

Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full time

Overview: The Principal Quality Systems Specialist plays a crucial role in ensuring the operational compliance of the site, encompassing areas such as Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation, all in alignment with established regulatory standards and organizational expectations. This position is responsible for overseeing the implementation and utilization of the Quality Management System (QMS) and may also contribute to global QMS initiatives while spearheading continuous improvement efforts.

Key Responsibilities:

  • Ensure adherence to quality standards across all facets of the Raheen site, including manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Uphold regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
  • Collaborate with cross-functional teams to address issues, conduct investigations, and maintain compliance.
  • Oversee QA review and approval for various document types, including:
    • Failure investigations
    • Corrective and Preventative Actions (CAPA)
    • Standard Operating Procedures (SOPs)
    • GxP documentation
    • Change control documentation
  • Review system records for assignment, compliance, and closure.
  • Provide administrative support for electronic systems.
  • Evaluate procedures, policies, and instructional documents related to quality systems to ensure alignment with company policies and regulatory requirements.
  • Monitor and trend metrics associated with site quality systems.
  • Actively engage in continuous improvement initiatives and implementation.
  • Participate in internal, regulatory, and customer audits.
  • Potentially train personnel on quality system processes.
  • May supervise team members.
  • Perform additional responsibilities as required.

Qualifications:

  • Principal Quality Systems Specialist: Requires a BS/BA in a scientific discipline or related field, along with 8 years of relevant industry experience or an equivalent combination of education and experience.
  • Senior Quality Systems Specialist: Requires a BS/BA in a scientific discipline or related field, with 5 years of relevant industry experience or an equivalent combination of education and experience.

Skills and Competencies:

  • Ability to build relationships and guide business users on QMS system requirements.
  • Strong written, verbal, and interpersonal communication skills, with the ability to effectively engage with diverse audiences.
  • Excellent time management, organizational skills, and a proven ability to manage multiple tasks simultaneously.
  • In-depth knowledge of quality principles, cGMP regulations, and relevant regulatory guidelines.
  • Demonstrates a results-oriented mindset, adaptability, and a keen attention to detail.
  • Project management capabilities with the ability to handle various tasks concurrently.
  • Effectively organizes and manages work responsibilities with minimal supervision.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

#JOBSIEPR #IRELIM #REGNIEQA #LI-Onsite

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