Inspection Readiness Lead - Quality Compliance (GxP)

Genentech

Holly Springs (MS)

On-site

USD 115,000 - 213,000

Full time

3 days ago

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Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, NC seeks a Principal Quality Compliance Specialist to lead the site self-inspection program and own inspection readiness for Health Authority reviews. You will guide risk assessments, coordinate SMEs for regulatory interactions, and drive continuous improvement across aseptic drug product manufacturing.

You will build a robust quality culture, partner with global functions, and oversee core quality systems to ensure compliance and operational excellence in a

Qualifications

Minimum 8–10 years in a GxP environment with site/global inspection readiness exposure.
Proven ability to coach SMEs and leadership for regulatory interactions.
Deep knowledge of FDA/EMA/ICH/ISO guidelines and their application in aseptic manufacturing.

Responsibilities

Lead the site self-inspection program and drive readiness for Health Authority inspections.
Coordinate risk assessments and deep-dive reviews across site operations and drive root-cause analysis.
Develop and execute the site inspection readiness strategy and regulatory engagement plans.
Maintain alignment with global quality/regulatory partners and support key quality systems.
Provide support for Quality Escalations, Recalls, Inspection Management, and Supplier Management.

Skills

GxP experience

Regulatory knowledge

Leadership

Regulatory interactions

Education

Bachelor's degree in a scientific/technical discipline

Job description

You will build a robust quality culture, partner with global functions, and oversee core quality systems to ensure compliance and operational excellence in a

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