QA Ops Lead: Viral PCU & Vaccine Manufacturing

Sanofi; Swiftwater (Monroe County); On-site; USD 110,000 - 160,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a QA OPS Manager – B79 Viral PCU Lead to steer the quality assurance operations for the B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will lead a team of QA professionals, ensure GMP compliance, manage quality events, investigations, risk controls, and batch release activities to safeguard product quality throughout the lifecycle.

You will collaborate with manufacturing and QA partners, drive continuous improvement, deliver regulatory-ready

Qualifications

• Bachelor’s Degree in life sciences, engineering, or related technology degree is required.
• Minimum 5 years of QA experience in the pharmaceutical industry.
• Strong knowledge of GMP and QA principles.
• Ability to analyze complex data and identify trends and solutions.
• High accuracy and attention to detail in QA activities.
• Strong verbal and written communication for regulatory interactions.
• Ability to manage multiple projects and meet deadlines.
• Fluent in English.
• Knowledge of visual inspection principles preferred.

Responsibilities

• Ensure site activities comply with regulatory requirements and maintain licenses.
• Ensure GMP compliance and other relevant regulations.
• Oversee daily QA ops team activities aligned with goals and regulatory needs.
• Close quality events (deviations, CAPAs, PQR, change controls) promptly.
• Oversee investigations related to product quality for risk and impact assessment.
• Conduct regular production process audits to spot quality issues.
• Collaborate with production to maintain quality throughout lifecycle.
• Manage and resolve quality-related issues promptly and effectively.
• Train and manage QA operations team.
• Monitor quality performance metrics and implement corrective actions.
• Lead root cause analyses for quality incidents and preventive actions.
• Participate in internal and external audits and regulatory inspections.
• Develop and implement risk management strategies to mitigate issues.
• Foster a culture of quality and continuous improvement.
• Oversee batch record review and release processes per GMP.
• Review and approve batch records and related documentation.
• Ensure batch release activities comply with GMP.

Skills

Quality assurance

GMP

Data analysis

Attention to detail

Communication skills

Multi-project management

English fluency

Visual inspection knowledge

Education

Bachelor’s Degree in life sciences, engineering, or related technology degree

Job description

Sanofi in Swiftwater, PA is seeking a QA OPS Manager – B79 Viral PCU Lead to steer the quality assurance operations for the B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will lead a team of QA professionals, ensure GMP compliance, manage quality events, investigations, risk controls, and batch release activities to safeguard product quality throughout the lifecycle.

You will collaborate with manufacturing and QA partners, drive continuous improvement, deliver regulatory-ready