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Lead Quality Systems Expert

2 months ago

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

Overview: The Principal Quality Systems Specialist plays a crucial role in ensuring the adherence to operational compliance across various domains including Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation, all in line with regulatory mandates and organizational standards. This position oversees the implementation and utilization of the Quality Management System (QMS) and may contribute to global QMS initiatives while spearheading continuous improvement efforts.

Key Responsibilities:

  • Ensure comprehensive compliance with quality standards at the site, covering 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.
  • Conduct QA reviews and approvals 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.
  • Participate in internal, regulatory, and customer audits.
  • May provide training to personnel on quality system processes.
  • Potentially supervise team members.
  • Undertake additional responsibilities as assigned.

Qualifications:

  • A Bachelor’s degree in a scientific discipline or related field is required, along with 8 years of relevant industry experience for the Principal Quality Systems Specialist role, or 5 years for the Senior Quality Systems Specialist role.

Skills and Competencies:

  • Ability to cultivate relationships and guide business users on QMS system requirements.
  • Strong written, verbal, and interpersonal communication skills, with the ability to effectively engage a diverse audience.
  • Excellent time management, organizational skills, and a proven capacity to handle multiple tasks simultaneously.
  • Knowledge of quality principles, cGMP standards, and relevant regulatory guidelines.
  • Demonstrates a results-oriented mindset, adaptability, and attention to detail.
  • Project management skills with the ability to manage various tasks concurrently.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

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