Senior Quality Assurance Specialist - Digital Apps (CVRM)

Genentech, Inc.; Holly Springs (NC); Vor Ort; USD 94.000 - 175.000; Vollzeit

Zusammenfassung

Genentech, Inc. in Holly Springs, NC seeks a Senior Quality Assurance Specialist, Digital Apps to anchor QA IT systems and ensure compliant digital quality operations at the new facility.

You will configure and maintain QA-owned applications, including SAP Quality modules and Tulip, to support automated batch release and data integrity. You will drive validation, testing, and change control, partnering with cross-functional teams to sustain a robust quality culture and enable rapid, compliant

Qualifikationen

• Bachelor's degree in a scientific, technical, or information systems discipline.
• Minimum 6–8 years of experience in a GxP environment, including 3+ years managing QA digital applications.
• Deep understanding of IT architecture, system interfaces, and data flows.

Aufgaben

• Lead configuration and maintenance of QA-owned digital systems.
• Oversee local IT system implementation aligned with timelines.
• Perform system testing during deployments and updates.
• Configure SAP Quality workflows and master data.
• Configure Tulip, Speca, Batch Release Hub for compliant site operations.
• Provide QA oversight for Tulip apps and other site apps.
• Support CSV activities across digital applications.
• Drive end-user training for supported digital systems.
• Own deviations, CAPAs, and change requests; audit trail reviews.

Kenntnisse

GxP environment

SAP Quality modules

IT architecture

Quality system validation

Lean/Six Sigma

Regulatory audits

Cross-functional leadership

Ausbildung

Bachelor's degree in a scientific/technical field

Advanced degree preferred

Tools

SAP Quality modules

Tulip

Speca

Batch Release Hub

Jobbeschreibung

The Position

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 Senior Quality Assurance Specialist, Digital Apps, who possesses extensive experience in quality, digital compliance, and system configuration. In this critical role, you will ensure any QA IT owned systems are configured and maintained correctly to enable seamless operations across the Holly Springs site. You will serve as the technical and compliance anchor for digital Quality applications.

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

• Lead the configuration, routine maintenance, and compliance oversight of QA-owned digital systems and applications.
• Oversee local IT system implementation strategies to ensure seamless alignment with project timelines and operational goals.
• Execute rigorous system testing during initial deployments and periodic system updates.
• Configure SAP Quality workflows and establish, maintain, and validate Master Data to support site-wide quality operations.
• Configure digital applications (including Speca, Batch Release Hub, and Tulip) to enable lean, efficient, and compliant site operations, with a core focus on automated batch release and CoA generation.
• Provide Quality oversight for custom Tulip digital applications, ensuring strict adherence to data integrity and digital application standards.
• Provide QA oversight and support to other apps owned by other site functions.
• Support computer systems validation (CSV) activities across digital applications.
• Drive end-user training programs for supported digital systems.
• Own deviation investigations, CAPAs, and Change Requests; perform periodic reporting, system evaluations, and audit trail reviews while serving as the local system administrator.
• Author, review, and approve standard operating procedures (SOPs), work instructions, monitoring protocols/reports, gap assessments, and risk assessments.

Who You Are

• Bachelor's degree in a scientific, technical, or information systems discipline (Advanced degree preferred).
• Minimum of 6–8 years of experience in a GxP environment, including 3+ years managing the setup and maintenance of QA digital applications.
• In-depth understanding of IT architecture, system interfaces, and end-to-end data flows to optimize operational workflows.
• Proven expertise in SAP master data governance, optimization, and life cycle management.
• Good working knowledge of manufacturing operations, specification management, product release and change / exception handling from the IT system and application perspective.
• Strong GMP and CSV expertise, with comprehensive knowledge of global regulatory requirements, including EU-GMP Annex 11 and Chapter 4 expectations.
• Hands-on experience configuring and administering SAP Quality modules and associated master data.
• Proven experience supporting health authority inspections and regulatory audits.
• Strong cross-functional leadership skills with a proven ability to influence stakeholders and global partners without direct authority.
• A proactive change agent comfortable with ambiguity, proficient in applying Lean/Six Sigma principles to enhance process efficiency and compliance.
• Agile and resilient in fast-paced environments, maintaining unwavering commitment to quality and compliance standards.

Relocation Assistance is not 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.