Inspection Lead, Quality Compliance – Greenfield Plant

Genentech; Holly Springs (NC); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, NC is building a state-of-the-art, high-throughput drug product manufacturing site focused on CVRM products. We seek a Principal Quality Compliance Specialist to serve as the site Inspection Lead, owning the self-inspection program and readiness for Health Authority inspections.

You will embed a risk-based Quality Culture, drive continuous improvement, and partner with global quality teams to ensure audit readiness and regulatory excellence across the site.

Qualifications

• Bachelor's degree in a scientific/technical discipline (advanced degree preferred).
• 8–10 years in a GxP environment with at least 3 years leading inspection readiness programs.
• Proven ability to coach SMEs and leadership for regulatory interactions.
• Expertise in FDA, EMA, ICH, ISO and their application in digital, sterile manufacturing and device packaging.
• Track record designing, overseeing, and executing robust site self-inspection programs.
• Exceptional cross-functional leadership and stakeholder management to drive improvement.
• Thrives in dynamic, fast-paced greenfield or start-up environments with rigorous compliance.

Responsibilities

• Lead, oversee, and continuously improve the site's self-inspection and internal audit strategy.
• Develop and execute the site's inspection readiness strategy to ensure continuous state of audit readiness.
• Coach and prepare SMEs for regulatory interactions.
• Manage Health Authority commitments, inspection responses, and post-inspection action tracking.
• Maintain alignment with global quality and regulatory partners to facilitate seamless health authority engagements.
• Provide support to core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.

Skills

GxP regulations

Inspections readiness

Cross-functional leadership

Coaching SMEs

Education

Bachelor's degree in a scientific/technical discipline

Job description

Genentech in Holly Springs, NC is building a state-of-the-art, high-throughput drug product manufacturing site focused on CVRM products. We seek a Principal Quality Compliance Specialist to serve as the site Inspection Lead, owning the self-inspection program and readiness for Health Authority inspections.

You will embed a risk-based Quality Culture, drive continuous improvement, and partner with global quality teams to ensure audit readiness and regulatory excellence across the site.