QA Ops Manager B79 Viral PCU Lead

Location: Swiftwater, Pennsylvania, United States; onsite. US and Puerto Rico residents only.

Salary: $113,250–$163,583 per year

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines to improve patients’ lives worldwide.

What you will do

• Lead quality oversight for B79 Viral Manufacturing, the B78 Seed Facility, and the QC Facility.
• Ensure site activities comply with regulatory requirements, manufacturing licenses, product permissions, and Good Manufacturing Practices.
• Lead the quality assurance team and oversee daily operations, training, performance metrics, and continuous improvement.
• Oversee deviations, OOS investigations, CAPAs, PQRs, change controls, risk assessments, and product impact assessments.
• Conduct process audits, support regulatory inspections, and implement remediation and preventive actions.
• Review and approve batch records and documentation, ensuring compliant batch disposition and release.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related technology field.
• At least 5 years of pharmaceutical quality assurance experience.
• Strong knowledge of GMP and quality assurance principles.
• Ability to analyze complex data, identify trends and problems, and implement corrective actions.
• Strong communication, organizational, and project management skills with high attention to detail.
• Fluent English required.

Nice to have

• Knowledge of visual inspection principles and requirements.

Culture & Benefits

• Work in a collaborative and technical vaccine manufacturing operation.
• Contribute to the development of life-saving vaccines.
• Access career growth opportunities through promotions and lateral moves.
• Receive healthcare, wellbeing, prevention, and wellness benefits.
• At least 14 weeks of gender-neutral parental leave.
• Work with digital, data, and AI-driven technologies supporting medicine and vaccine delivery.