Principal QMS Specialist (Biotech)

TL;DR

Principal QMS Specialist (Biotech): Managing and overseeing Quality Management Systems for CVRM operations with an accent on regulatory compliance, process optimization, and quality oversight. Focus on ensuring adherence to FDA standards, driving continuous improvement in quality systems, and supporting complex biotechnology manufacturing processes.

Location: Must be based in Holly Springs, North Carolina, USA

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Oversee and maintain Quality Management Systems (QMS) to ensure compliance with internal and external regulatory requirements.
• Lead quality initiatives and process improvements within the CVRM department.
• Collaborate with cross-functional teams to address quality issues and implement corrective and preventive actions (CAPA).
• Provide expert guidance on quality standards and regulatory expectations.
• Support audits and inspections to ensure operational readiness and compliance.

Requirements

• Must be based in Holly Springs, North Carolina
• Extensive experience in Quality Management Systems within the biotechnology or pharmaceutical industry.
• Strong understanding of FDA regulations and quality compliance standards.
• Proven ability to lead quality-focused projects and cross-functional teams.

Culture & Benefits

• Work for a pioneer in the biotechnology industry with a long-standing commitment to R&D.
• Join a team recognized for being on the Fortune 100 Best Companies to Work For list for 24 years.
• Contribute to the development of life-changing medicines for serious diseases.