Quality Assurance Manager (Sterile Pharmaceutical Manufacturing)

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

Company

hirify.global is a Virginia-based contract manufacturing organization specializing in small-batch sterile pharmaceutical manufacturing, filling, packaging, labeling, and analytical services.

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 analyses, and compliant resolutions.
• 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 while partnering with Manufacturing, Quality Control, and Regulatory Affairs on quality standards and continuous improvement.

Requirements

• Bachelor’s degree in biology or a related field.
• Strong working knowledge of FDA regulations, EU GMP, and Annex 1.
• Professional experience with lot release, deviation management, and CAPA systems.
• Experience supporting FDA and client regulatory inspections and audits.
• Strong problem-solving, communication, leadership, and cross-functional collaboration skills.
• Ability to work on-site in Charlottesville, Virginia.

Nice to have

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

Culture & Benefits

• Work in a growth-oriented pharmaceutical manufacturing environment focused on quality, reliability, and healthcare impact.
• Collaborate with manufacturing, quality control, engineering, and regulatory teams.
• Access opportunities for professional development, learning, and staff training.
• Support personnel qualification and training for aseptic operations, including media fills and gowning qualifications.
• Reasonable accommodation is available for individuals with disabilities as required by law.