QA Ops Leader — Viral Vaccine PCU Lead

Sanofi; Pocono Township (PA); On-site; USD 113,000 - 164,000; Full time

Job summary

Sanofi seeks a QA OPS Manager – B79 Viral PCU Lead in Swiftwater, PA to lead quality assurance for B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will oversee a skilled QA team, ensure GMP compliance, and drive investigations, audits, and improvements across the product lifecycle.

Ideal candidates have 5+ years in pharmaceutical QA, strong GMP knowledge, data analysis skills, and fluent English.

Qualifications

• Minimum 5 years of experience in quality assurance within the pharmaceutical industry.
• Strong knowledge of Good Manufacturing Practices (GMP) and QA principles.
• Ability to analyze complex data and identify trends, issues, and solutions.
• High accuracy and attention to detail in QA activities.
• Strong written and verbal communication for regulatory interactions.
• Ability to manage multiple projects simultaneously and meet timelines.
• Fluent in English.
• Knowledge of visual inspection principles preferred.

Responsibilities

• Oversee QA team activities to ensure regulatory compliance and quality goals.
• Lead batch release processes in GMP environments.
• Manage investigations for deviations, CAPAs, PQRs, and change controls.
• Conduct regular audits of production processes to identify quality issues.
• Collaborate with production to maintain quality across the product lifecycle.
• Train and develop the QA operations team.
• Monitor quality performance metrics and implement improvements.
• Lead root cause analyses and preventive actions.
• Support internal and external audits and regulatory inspections.

Skills

GMP knowledge

Quality assurance

Data analysis

Communication skills

Multitasking

Education

Bachelor's Degree in life sciences

Engineering or related technology degree

Job description

Sanofi seeks a QA OPS Manager – B79 Viral PCU Lead in Swiftwater, PA to lead quality assurance for B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will oversee a skilled QA team, ensure GMP compliance, and drive investigations, audits, and improvements across the product lifecycle.

Ideal candidates have 5+ years in pharmaceutical QA, strong GMP knowledge, data analysis skills, and fluent English.