Sr. Quality Systems Specialist

• Provide oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and industry standards.
  

• Ensure the performance and quality of services conform to establishedQuality System standards, agency guidelines, and company expectations.
  

• Offer expertise and guidance in interpreting regulatory, governmental, and internal quality policies to maintain compliance across operations.
  

• Partner with operating entities to analyze processes, ensure requirement alignment, and drive continuous improvement initiatives.
  

• Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit and inspection findings.
  

• Act as liaison with internal/external auditing groups and regulatory inspectors throughout the entire audit lifecycle.
  

• Coordinate legal and quality documentation requests in support of government investigations or litigations.
  

• Maintain and regularly update quality assurance programs, procedures, and documentation to align with evolving standards and regulatory expectations.
  

• Promote uniform global quality standards and facilitate best-practice sharing across sites and teams.
  

• Other duties may be assigned.
  

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Requirements

• Minimum of 4 years of relevant experience in the regulated industry. 
  

• Strong investigation skills with demonstrated root cause analysis capabilities.
  
• Proficient technical writing, strong organization, and effective communication skills.
  
• Experience in Process Validation and Computer Software Validation (CSV).
  

• Bachelor’s Degree completed with a minimum of 4 years of relevant experience.
  
• Master's degree with a minimum of 2 years of relevant experience.
  
• *Willing to work 100% on-Site in Juncos,PR.*