Senior R&D Quality & Operations Lead

Regulatory Jobs; Pennsylvania; Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

GSK US is seeking an experienced Quality professional to deliver operational quality activities that protect patient safety and ensure reliable supply across manufacturing and supplier networks in the United States.

You will lead quality governance, approve GMP documentation, participate in investigations and CAPA, support regulatory inspections, and drive continuous improvement with cross-functional teams to sustain compliant, high‑quality product supply.

Qualifikationen

• Bachelor’s degree required in scientific, engineering, pharmacy, or related discipline.
• Minimum 5 years of experience in quality roles in a highly regulated environment.
• Fluency in both written and verbal English.

Aufgaben

• Develop and implement Quality R&D operations processes for site readiness.
• Approve GMP documentation and participate in investigations and CAPA.
• Participate in audits and regulatory inspections; identify risks and propose mitigation.
• Support Quality Management System and training for customers and partners.
• Advise GSK project teams to reduce regulatory risk.
• Identify changes impacting quality across departments and provide leadership.
• Review GMP docs, drive root cause analyses and CAPA closure.
• Support product introductions, transfers, and monitor quality metrics.

Kenntnisse

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Ausbildung

Bachelor’s degree in scientific, engineering, pharmacy, or related discipline

Jobbeschreibung

GSK US is seeking an experienced Quality professional to deliver operational quality activities that protect patient safety and ensure reliable supply across manufacturing and supplier networks in the United States.

You will lead quality governance, approve GMP documentation, participate in investigations and CAPA, support regulatory inspections, and drive continuous improvement with cross-functional teams to sustain compliant, high‑quality product supply.