Sterility Assurance Lead (CVRM)

TL;DR

Sterility Assurance Lead (CVRM): Building and overseeing the entire sterility assurance framework for a new greenfield drug product manufacturing facility with an accent on aseptic processing, contamination control, and regulatory compliance. Focus on designing robust sterility standards, leading complex microbiological investigations, and ensuring the facility meets global regulatory requirements for next-generation metabolic medicines.

Location: Must be based in or able to relocate to Holly Springs, North Carolina, USA

Salary: $141,200–$262,200

Company

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

What you will do

• Build the entire sterility assurance framework from the ground up, covering design, commissioning, and commercial operations.
• Establish and implement a comprehensive Contamination Control Strategy (CCS) aligned with global standards.
• Review and approve facility and equipment design specifications for aseptic processing zones and material flows.
• Lead complex microbiological investigations, including sterility failures and environmental monitoring excursions, to determine root causes and implement CAPA.
• Develop and deliver specialized training programs for manufacturing and quality personnel on aseptic techniques and cleanroom behaviors.
• Serve as the subject matter expert during regulatory inspections and dossier preparation regarding sterility assurance.

Requirements

• Bachelor’s degree in Microbiology, Biology, Chemical Engineering, or related scientific discipline (Master’s or PhD preferred).
• 12+ years of experience in Quality Assurance or Microbiology in the pharmaceutical or biotechnology industry.
• At least 5 years dedicated to Sterility Assurance in an aseptic manufacturing environment.
• Expert-level knowledge of global regulations (cGMP, GLP, FDA, EU Annex 1).
• Proven experience in the commissioning, qualification, and start-up of a new or renovated sterile manufacturing facility.
• Ability to strategically influence facility design and process flows from a sterility assurance perspective.

Culture & Benefits

• Opportunity to launch a $2B state-of-the-art greenfield facility from the ground up.
• Entrepreneurial environment with high accountability and impact on the future of medicine.
• Relocation assistance provided for eligible candidates.
• Competitive compensation package including discretionary annual bonus.
• Work within a globally recognized organization committed to groundbreaking scientific discovery.