Principal Quality Compliance Specialist, Inspection (CVRM)

Genentech; Holly Springs (MS); Sur place; USD 115 000 - 213 000; Plein temps

Avantages offerts par ce poste

Relocation assistance

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GxP experience

Regulatory knowledge

Leadership

Regulatory interactions

Formation

Bachelor's degree in a scientific/technical discipline

Description du poste

Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.

Join us in Holly Springs, where you won't just build a plant-you will build the future of medicine.

The Opportunity

We seek a highly impactful Principal Quality Compliance Specialist who will serve as the site Inspection Lead. In this critical role, you will oversee the execution of the site self-inspection program and fully own the site's inspection readiness and response strategy for Health Authority inspections. As the site Inspection Lead, you will serve as the foundational compliance anchor and will play a vital role to maintain a continuous state of audit readiness.

This position is a unique opportunity to embed a robust, risk-oriented Quality Culture into the site's operational design, lead Health Authority engagement, support continuous improvement, and drive operational excellence, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.

What You'll Do

• Self-Inspection Program: Lead, oversee, and continuously improve the site's self-inspection and internal audit strategy.
• Coordinate targeted deep-dive assessments and complex risk assessments across site operations.
• Ensure timely remediation of identified self-inspection findings and drive root-cause analysis.
• Own the Inspection Readiness Program: Develop and execute the site's inspection readiness strategy to ensure continuous state of audit readiness.
• Translate global compliance trends and regulatory mandates into actionable site plans and controls.
• Partner cross-functionally to coach and prepare subject matter experts for regulatory interactions.

Core Quality Compliance Support

• 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.
• Support key compliance processes, including Quality Escalations, Recalls, Inspection Management, Site Master File, Management Reviews, and Supplier Management.

Who You Are

• Bachelor's degree in a scientific/technical discipline (Advanced degree preferred).
• Minimum 8-10 years in a GxP environment, with at least 3 years leading site or global inspection readiness programs.
• Proven ability to coach, prepare, and align subject matter experts (SMEs) and leadership teams for high-stakes regulatory interactions, and managing post-inspection commitments.
• Expertise in global GxP regulations (FDA, EMA, ICH, ISO) and their application in digital, sterile manufacturing and device packaging environments.
• Demonstrated track record of designing, overseeing, and executing robust site self-inspection program.
• Exceptional cross-functional leadership, communication, and stakeholder management skills to influence continuous improvement without formal authority.
• Thrives in dynamic, fast-paced greenfield or start-up environments while upholding rigorous compliance and operational standards.

Relocation assistance is available for this role.

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $114,700 - $212,900. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of