Senior Quality Assurance Specialist - Digital Apps (CVRM)

Genentech•Holly Springs, NC

11d•Onsite

About The Position

Genentech seeks a Senior Quality Assurance Specialist, Digital Apps, to provide quality, digital compliance, and system configuration expertise at its Holly Springs, North Carolina manufacturing facility. The role serves as the technical and compliance anchor for digital Quality applications, ensuring QA-owned systems are correctly configured and maintained to support site operations. It offers the opportunity to help establish a risk-oriented Quality Culture, support continuous improvement, and advance operational excellence at a new facility planned to launch in 2028. The specialist leads configuration, maintenance, and compliance oversight for QA-owned digital systems; supports implementation strategies, testing, and computer systems validation; and configures SAP Quality workflows and master data. The role also supports applications such as Speca, Batch Release Hub, and Tulip, with an emphasis on automated batch release and certificates of analysis. Additional responsibilities include training users, administering systems, managing quality events and changes, conducting periodic evaluations and audit trail reviews, and authoring and approving controlled documentation. The position is based in Holly Springs, North Carolina. Relocation assistance is not available. The expected salary range is $94,000–$174,600, and a discretionary annual bonus may be available based on individual and company performance. The position qualifies for benefits detailed through a link in the posting.

Requirements

Bachelor's degree in a scientific, technical, or information systems discipline.
Minimum of 6–8 years of experience in a GxP environment, including 3+ years managing setup and maintenance of QA digital applications.
In-depth understanding of IT architecture, system interfaces, and end-to-end data flows.
Expertise in SAP master data governance, optimization, and life cycle management.
Working knowledge of manufacturing operations, specification management, product release, and change and exception handling from an IT system and application perspective.
Strong GMP and CSV expertise, including knowledge of global regulatory requirements such as EU-GMP Annex 11 and Chapter 4 expectations.
Hands-on experience configuring and administering SAP Quality modules and associated master data.
Experience supporting health authority inspections and regulatory audits.
Strong cross-functional leadership and ability to influence stakeholders and global partners without direct authority.
Proactive change-agent approach and ability to apply Lean/Six Sigma principles to improve process efficiency and compliance.
Ability to work in fast-paced environments with ambiguity while maintaining quality and compliance standards.

Nice To Haves

Advanced degree.
Experience configuring digital applications such as Speca, Batch Release Hub, and Tulip.

Responsibilities

Lead configuration, routine maintenance, and compliance oversight of QA-owned digital systems and applications.
Oversee local IT system implementation strategies to align with project timelines and operational goals.
Execute system testing during initial deployments and periodic system updates.
Configure SAP Quality workflows and establish, maintain, and validate master data for site-wide quality operations.
Configure digital applications, including Speca, Batch Release Hub, and Tulip, to support lean, efficient, and compliant operations, especially automated batch release and CoA generation.
Provide Quality oversight for custom Tulip applications and ensure adherence to data integrity and digital application standards.
Provide QA oversight and support for applications owned by other site functions.
Support computer systems validation 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; and serve as the local system administrator.
Author, review, and approve SOPs, work instructions, monitoring protocols and reports, gap assessments, and risk assessments.