Senior Quality Assurance Specialist - Digital Apps (CVRM)

Location: Holly Springs, North Carolina, United States of America; onsite role. Relocation assistance is not available.

Expected salary: $94,000–$174,600 per year, with a discretionary annual bonus potentially available.

Company

Biotechnology and pharmaceutical operations are being established at a new $2B facility focused on high-volume CVRM drug product manufacturing, advanced automation, robotics, digital tools, and real-time data analytics.

What you will do

• Lead configuration, routine maintenance, compliance oversight, testing, and implementation of QA-owned digital systems.
• Configure SAP Quality workflows and manage validated master data for site-wide quality operations.
• Configure Speca, Batch Release Hub, and Tulip applications, with a focus on automated batch release and CoA generation.
• Provide quality oversight for custom Tulip applications and support applications owned by other site functions.
• Support computer systems validation, user training, audit-trail reviews, system evaluations, and periodic reporting.
• Own deviation investigations, CAPAs, change requests, SOPs, work instructions, monitoring protocols, gap assessments, and risk assessments.

Requirements

• Bachelor’s degree in a scientific, technical, or information systems discipline; an advanced degree is preferred.
• 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.
• Expertise in SAP master data governance, optimization, lifecycle management, and hands-on administration of SAP Quality modules.
• Working knowledge of manufacturing operations, specification management, product release, and change or exception handling from an IT systems perspective.
• Strong GMP and CSV expertise, including global regulatory requirements such as EU-GMP Annex 11 and Chapter 4.
• Experience supporting health authority inspections and regulatory audits.
• Strong cross-functional leadership and stakeholder influence without direct authority.
• Ability to apply Lean/Six Sigma principles in ambiguous, fast-paced environments while maintaining quality and compliance standards.

Nice to have

• Advanced degree in a scientific, technical, or information systems discipline.

Culture & Benefits

• Entrepreneurial, fast-paced environment with high accountability and a focus on operational excellence.
• Opportunity to help launch a state-of-the-art manufacturing facility planned for 2028.
• Benefits are provided according to the company’s benefits program.
• A discretionary annual bonus may be available based on individual and company performance.