The OpportunityWe 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.
