QA Ops Lead — Viral PCU (Vaccine Manufacturing)

Sanofi; Pennsylvania; Vor Ort; USD 113.000 - 164.000; Vollzeit

Benefits dieser Stelle

14 weeks parental leave

Healthcare benefits

Zusammenfassung

Sanofi in Swiftwater, PA is seeking a QA OPS Manager – B79 Viral PCU Lead to oversee quality oversight of B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will lead a team ensuring GMP compliance, batch release readiness, and effective CAPA closures across the vaccine production lifecycle.

Ideal candidates have a life sciences degree, 5+ years in pharma QA, strong regulatory knowledge, and proven leadership in quality operations.

Qualifikationen

• Bachelor’s Degree in life sciences, engineering, or related technology required.
• 5+ years of quality assurance experience in pharmaceutical industry.
• Strong GMP knowledge and QA principles.
• Excellent written and verbal communication with regulatory bodies.

Aufgaben

• Ensure site activities comply with regulatory requirements and maintain licenses.
• Oversee daily QA team operations and ensure alignment with regulatory needs.
• Close quality events timely: deviations, CAPAs, PQRs, change controls.
• Lead investigations for quality incidents with appropriate risk and impact assessments.
• Conduct regular audits of production processes and collaborate with production on quality.
• Manage and resolve quality issues promptly and implement preventive measures.
• Provide training and supervision to QA operations team.
• Review and approve batch records and support batch disposition.

Kenntnisse

Strong communication

Fluent English

Attention to detail

Project management

Ausbildung

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

Jobbeschreibung

Sanofi in Swiftwater, PA is seeking a QA OPS Manager – B79 Viral PCU Lead to oversee quality oversight of B79 Viral Manufacturing, B78 Seed Facility and QC Facility. You will lead a team ensuring GMP compliance, batch release readiness, and effective CAPA closures across the vaccine production lifecycle.

Ideal candidates have a life sciences degree, 5+ years in pharma QA, strong regulatory knowledge, and proven leadership in quality operations.