Inspection Readiness Leader, Quality Compliance (GxP)

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

Avantages offerts par ce poste

Relocation assistance

Discretionary annual bonus

Résumé du poste

Genentech, a member of the Roche group, seeks a Principal Quality Compliance Specialist to lead the site inspections and drive a robust inspection readiness program at the Holly Springs, NC facility. You will oversee Health Authority engagements, coordinate risk assessments, and integrate global regulatory expectations into site-level controls.

You will coach SMEs and leadership to align on regulatory expectations, manage post-inspection commitments, and contribute to continuous improvement in a

Qualifications

• Bachelor's degree in a scientific/technical discipline; advanced degree preferred.
• Experience leading site/global inspection readiness programs.
• Proven ability to coach SMEs and leadership for regulatory interactions.

Responsabilités

• Lead site self-inspection and internal audit strategy.
• Coordinate risk assessments across site operations.
• Ensure timely remediation of findings and drive root-cause analysis.
• Own the Inspection Readiness Program and audit readiness.
• Translate regulatory trends into actionable site plans and controls.
• Coach SMEs for regulatory interactions and inspections.

Connaissances

GxP regulations

Inspection readiness

Cross-functional leadership

Regulatory interactions

Formation

Bachelor's in science/engineering

Advanced degree preferred

Description du poste

Genentech, a member of the Roche group, seeks a Principal Quality Compliance Specialist to lead the site inspections and drive a robust inspection readiness program at the Holly Springs, NC facility. You will oversee Health Authority engagements, coordinate risk assessments, and integrate global regulatory expectations into site-level controls.

You will coach SMEs and leadership to align on regulatory expectations, manage post-inspection commitments, and contribute to continuous improvement in a