Senior Quality Compliance Lead: Inspection Readiness

F. Hoffmann-La Roche AG; Holly Springs (NC); Sur place; USD 115 000 - 213 000; Plein temps

Avantages offerts par ce poste

Relocation assistance

Résumé du poste

Genentech, part of Roche, is seeking a Principal Quality Compliance Specialist in Holly Springs, NC to lead the site self-inspection program and manage Health Authority inspections. You will own the inspection readiness strategy and coordinate cross-functional teams to ensure audit readiness across the site.

Ideal candidates have 8–10 years in a GxP environment, deep regulatory expertise, and a proven ability to coach SMEs and leadership for regulatory interactions.

Qualifications

• Minimum 8–10 years in a GxP environment with 3+ years leading inspection readiness programs.
• Expertise in global GxP regulations (FDA, EMA, ICH, ISO) and their application to manufacturing.
• Proven ability to coach SMEs and leadership for regulatory interactions and post-inspection commitments.
• Exceptional cross-functional leadership and stakeholder management without formal authority.

Responsabilités

• Lead, oversee, and continuously improve the site self-inspection strategy.
• Own the inspection readiness program and ensure audit readiness.
• Coordinate risk assessments and drive root-cause analysis.
• Manage Health Authority commitments and post-inspection actions.
• Collaborate with global quality and regulatory partners to facilitate engagements.
• Support core quality systems and compliance processes.

Connaissances

Cross-functional leadership

Regulatory coaching

Stakeholder management

Regulatory communications

GxP expertise

Quality systems

Formation

Bachelor’s degree in science/engineering

Advanced degree preferred

Description du poste

Genentech, part of Roche, is seeking a Principal Quality Compliance Specialist in Holly Springs, NC to lead the site self-inspection program and manage Health Authority inspections. You will own the inspection readiness strategy and coordinate cross-functional teams to ensure audit readiness across the site.

Ideal candidates have 8–10 years in a GxP environment, deep regulatory expertise, and a proven ability to coach SMEs and leadership for regulatory interactions.