Senior Quality Compliance Specialist, CVRM (Holly Springs)

Roche; South San Francisco (CA); On-site; USD 94,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, NC is seeking a Senior Quality Compliance Specialist to embed a risk-based quality culture and data integrity into aseptic drug product manufacturing. You will lead QRM, data integrity, and change control programs across cross-functional teams.

This role collaborates with Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global organizations to ensure compliance with FDA/EMA/ICH/ISO standards, manage inspections, and drive continuous improvement at a site

Qualifications

• Minimum 8–10 years in a GxP environment with at least 4 years leading QRM, Data Integrity or Change Control at a manufacturing site.
• Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and practical application in a digital sterile manufacturing landscape.
• Experience developing, auditing, or implementing site-wide Data Integrity compliance programs within highly automated/digital facilities.

Responsibilities

• Oversee Quality Risk Management, Data Integrity, and Change Control programs.
• Lead site Change Review Board and cross-functional approval of high-impact changes.
• Provide oversight of core quality systems to ensure compliance and continuous improvement.
• Engage with Health Authority inspections and regulatory interactions.

Skills

Quality risk management

Data integrity

Change control

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree in science/engineering

Job description

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 are looking for a highly impactful Senior Quality Compliance Specialist with broad experience, a robust risk-based operational focus, and a strong compliance mindset. This critical role is essential for guaranteeing the integration of risk based principles and data integrity controls into the operational design of our processes to deliver top-quality products, consistently meeting global regulatory requirements and Roche’s stringent internal standards.

As a key member of the Quality Compliance team, you will hold strategic responsibility for the comprehensive design and implementation of the site’s Quality Risk Management and Data Integrity initiatives. You will work in tandem with a variety of cross-functional partners, including Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global organizations, to proactively identify and address risks, establishing a robust, risk-oriented Quality Culture throughout the site.

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

What You’ll Do

• Quality Risk Management (QRM)
• Data Integrity
• Change Control
• Serve as site subject matter expert for change control.
• Chair the site Change Review Board, providing cross-functional leadership to evaluate, challenge, and approve high-impact modifications during commissioning, validation, and commercial phases.
• Drive consistent execution of the change control program.
• Core Quality Compliance Support
• Partners cross-functionally to drive a proactive, risk-based quality culture providing technical and organizational leadership toward resolving compliance issues.
• Provide oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
• Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management and Metrics & Reporting.
• Support compliance processes, including Quality Escalations, Product Recalls, Inspection Management, Self inspection, the Site Master File, Management Review, Supplier Management, Metrics & Reporting and Health Authority engagement..
• Serves as subject matter expert on global regulated requirements and inspectional commitments, assessing the state of compliance and participation in the action plans to correct deficiencies.
• Serve as the site contact to engage with global stakeholders regarding compliance trends, knowledge sharing and improvement initiatives.

Who You Are

• Bachelor’s degree in a scientific/technical discipline (Advanced degree preferred).
• Minimum of 8–10 years in a GxP environment, with at least 4 years of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site.
• Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape for sterile drug product manufacturing and device assembly and packaging.
• Experienced with the translation of QRM methodologies into operational controls for drug and combination products.
• Demonstrated success developing, implementing, or auditing site-wide Data Integrity compliance programs within highly automated/digital facility footprints.
• Broad experience across Quality and/or operations preferred.
• Extensive experience with regulatory inspections and health authority interactions.
• Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.
• You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

Relocation Assistance is available for this role.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $94,000 - $174,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

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 Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.