QA Supervisor - Operations - 1st Shift (369) (Pharmaceutical Manufacturing)

Location: Onsite in Petersburg, Virginia, United States; limited occasional travel may be required.

Company

hirify.global is a nonprofit pharmaceutical organization developing and manufacturing affordable generic sterile injectable medications to help prevent drug shortages.

What you will do

• Establish and maintain quality systems, procedures, and training for sterile manufacturing operations.
• Provide quality oversight on the shop floor, including real-time batch record review, batch disposition, deviations, and corrective actions.
• Support aseptic process simulations, terminal sterilization, equipment qualification, validation, and product or process transfers.
• Ensure compliance with FDA, DEA, CGMP, and Good Distribution Practice requirements.
• Lead quality activities across change control, CAPA, investigations, labeling, laboratory controls, complaints, and annual product quality reviews.
• Provide direction and support to operators and associates, promoting quality, safety, competence, and compliant execution.

Requirements

• Bachelor’s degree in a scientific discipline and at least 5 years of quality or CGMP experience in the pharmaceutical industry.
• Required experience in sterile injectable manufacturing and packaging operations.
• Experience across the product development and commercialization lifecycle, including regulatory agency inspection activities.
• Strong project management, organization, execution, interpersonal, written communication, and software skills.
• Ability to work autonomously and collaboratively in a small, fast-paced environment while following established procedures.
• Prior supervisory experience is highly desired.

Nice to have

• Experience with DEA requirements for handling and distributing controlled substances.

Culture & Benefits

• Work in a newly forming team supporting a state-of-the-art sterile injectable manufacturing facility.
• Contribute to the reliable supply of essential medicines and biosimilar insulins.
• Safety, quality excellence, continuous learning, and knowledge sharing are emphasized.
• Physical work may include standing, walking, handling objects, and occasionally lifting up to 25 pounds.
• The workplace is drug-free and complies with applicable ADA regulations.