Quality Assurance Manager

Location: On-site facility in Charlottesville, Virginia, United States

Company

hirify.global provides sterile pharmaceutical manufacturing services focused on quality, reliability, and regulatory compliance.

What you will do

• Lead quality oversight for sterile and non-sterile manufacturing operations in accordance with FDA regulations, EU GMP requirements, and Annex 1 guidance.
• Review batch records and supporting documentation for product quality, data integrity, and lot disposition.
• Lead deviation investigations, root cause analysis, and compliant resolution activities.
• Develop, implement, and track Corrective and Preventive Actions (CAPAs).
• Review and approve SOPs, protocols, and validation documentation for sterilization, aseptic filling, cleaning, and gowning.
• Support audits and regulatory inspections, monitor quality metrics, and provide quality systems guidance and training.

Requirements

• Bachelor’s degree in biology or a related field.
• Strong working knowledge of FDA regulations, EU GMP, and Annex 1.
• Proven experience with lot release, deviation management, and CAPA systems.
• Experience supporting FDA and client regulatory inspections and audits.
• Strong problem-solving, communication, and leadership skills.

Nice to have

• Experience with electronic quality management systems (eQMS).
• Understanding of risk management principles such as ICH Q9.
• Ability to manage multiple priorities in a fast-paced environment.

Culture & Benefits

• Work in an on-site sterile pharmaceutical manufacturing environment.
• Collaborate with Manufacturing, Quality Control, Regulatory Affairs, and Engineering.
• Contribute to continuous improvement and product sterility assurance.
• Provide guidance and training to QA personnel and cross-functional teams.
• The role may involve extended periods of sitting, standing, or walking and working in a standard office environment.