Senior Quality Assurance Specialist - Digital Apps (CVRM)

Genentech; Holly Springs (NC); On-site; USD 94,000 - 175,000; Full time

Job summary

Genentech, Inc. in Holly Springs, North Carolina, is seeking a Senior Quality Assurance Specialist for Digital Apps to ensure QA IT systems are configured and maintained to enable seamless operations at our new manufacturing campus.

This role emphasizes compliance, data integrity, and system governance in a fast-paced pharmaceutical environment. You will own validation, risk management, and oversee applications such as SAP Quality, Tulip, Speca, and Batch Release Hub, driving continuous

Qualifications

• Minimum 6–8 years in a GxP environment with 3+ years on QA digital applications.
• Strong GMP and CSV knowledge with global regulatory requirements.
• Experience configuring SAP Quality modules and master data.

Responsibilities

• Lead QA IT systems configuration, maintenance, and compliance for QA-owned digital apps.
• Oversee local IT system implementations aligned with project timelines.
• Conduct system testing during deployments and updates.
• Configure SAP Quality workflows and master data for site-wide quality ops.
• Set up Tulip and other digital apps for lean, compliant site operations.
• Provide QA oversight for Tulip apps and data integrity.
• Support CSV activities across digital apps.
• Develop end-user training for supported systems.
• Own deviation investigations, CAPAs, Change Requests; facilitate audits.
• Create and review SOPs and risk assessments.

Skills

GxP compliance

SAP experience

Quality systems

Cross-functional leadership

Lean Six Sigma

Agile mindset

Education

Bachelor's degree in a scientific/technical field

Tools

SAP Quality modules

Tulip

Speca

Batch Release Hub

Job description

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.