Senior Quality Assurance Specialist - Digital Apps (CVRM)
About The Position
The Senior Quality Assurance Specialist, Digital Apps, serves as the technical and compliance anchor for Quality-owned digital applications at Genentech’s Holly Springs, North Carolina site. The role ensures QA IT systems are appropriately configured and maintained to support compliant, seamless site operations and helps embed a risk-oriented Quality Culture while advancing continuous improvement and operational excellence for aseptic drug product manufacturing. The specialist leads configuration, maintenance, compliance oversight, and implementation support for QA-owned digital systems. Applications include SAP Quality workflows, Speca, Batch Release Hub, and Tulip, with a focus on automated batch release and Certificate of Analysis (CoA) generation. The role supports computer systems validation, system testing, data integrity, user training, and quality oversight of digital applications owned by other site functions. It also administers deviations, CAPAs, change requests, periodic evaluations, reporting, audit trail reviews, and controlled documentation.
Requirements
- Bachelor’s degree in a scientific, technical, or information systems discipline.
- 6–8 years of experience in a GxP environment, including at least 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.
- 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.
- Ability to apply Lean/Six Sigma principles to improve process efficiency and compliance.
- Comfort with ambiguity and resilience in a fast-paced environment, with a consistent commitment to quality and compliance.
Nice To Haves
- Advanced degree.
- Experience in a fast-paced manufacturing environment.
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 Speca, Batch Release Hub, Tulip, and other digital applications to support lean, efficient, compliant operations, focusing on 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 to applications owned by other site functions.
- Support computer systems validation (CSV) activities across digital applications.
- Develop and deliver end-user training 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 SOPs, work instructions, monitoring protocols and reports, gap assessments, and risk assessments.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits are available as detailed at the link provided in the job posting; specific benefits are not listed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
