Lead Quality Systems Expert

2 weeks ago

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

Overview: The Principal Quality Systems Specialist plays a crucial role in ensuring that the operations at Regeneron Pharmaceuticals, Inc. adhere to compliance standards across various functions, including Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation. This position is integral in overseeing the implementation and utilization of the Quality Management System (QMS), while also contributing to global QMS initiatives and leading continuous improvement projects.

Key Responsibilities:

  • Ensure adherence to quality compliance for all operational aspects at the site, including manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Maintain regulatory compliance in line with current Good Manufacturing Practices (cGMP).
  • Collaborate with cross-functional teams to address issues, conduct investigations, and uphold compliance standards.
  • Oversee QA review and approval processes for various documentation types, including:
    • Failure investigations
    • Corrective and Preventative Actions (CAPA)
    • Standard Operating Procedures (SOPs)
    • GxP documentation
    • Change control documentation
  • Review system records to ensure 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 analyze metrics associated with site quality systems.
  • Actively engage in the initiation and implementation of continuous improvement initiatives.
  • Participate in internal, regulatory, and customer audits.
  • Potentially train personnel on quality system processes.
  • May supervise team members as required.
  • Perform additional responsibilities as assigned.

Qualifications:

  • A Bachelor’s degree in a scientific discipline or related field, along with 8 years of relevant industry experience, or an equivalent combination of education and experience.
  • For Senior Quality Systems Specialist roles, a Bachelor’s degree in a scientific discipline or related field with 5 years of relevant industry experience is required.

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 the capacity to manage multiple tasks simultaneously.
  • Knowledge of quality principles, cGMP standards, and relevant regulatory guidelines.
  • Demonstrated drive for results, adaptability in ambiguous situations, and a keen attention to detail.
  • Project management capabilities, with the ability to handle various tasks concurrently.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

#JOBSIEPR #IRELIM #REGNIEQA #LI-Onsite

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