Senior QA Specialist: Manufacturing Quality & Compliance

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Relocation benefits available

Job summary

Genentech in Holly Springs, NC seeks a Principal QA Specialist with extensive GxP experience to ensure quality for Assembly, Packaging and Warehouse operations.

You will lead quality oversight, drive continuous improvement, collaborate with MSAT, Operations, and Global teams, and embed Quality by Design into site processes while supporting regulatory readiness and CAPA/Deviations approval.

Qualifications

• Bachelor's degree in a scientific discipline (graduate or higher-level degree strongly preferred).
• 8–10 years in a GxP environment, with at least 4 years of Device assembly and packaging experience in manufacturing, QA Operations or MSAT.
• Experience with pre-filled syringes or autoinjectors preferred.
• Strategic and systems thinker with a compliance focus, driving operational excellence in execution.
• Advanced GMP and quality regulation knowledge with experience in global regulatory inspections (FDA, EMA).
• Expertise in Quality Assurance, including deviation management, CAPA, and product release processes.
• Experience leading complex investigations and strong technical writing skills.
• Hands-on experience with SAP and MES.

Responsibilities

• Quality by Design: establish procedures for Assembly, Packaging and Warehouse with risk-based controls.
• Quality Management: approve procedures and drive continuous improvement.
• Digital Quality: design recipes and Manufacturing Batch Records with MES and SAP.
• Release by Exception: define critical parameters for automatic verification.
• Design & Commissioning Phase: support equipment/process reviews and PQ readiness.
• Investigations: lead root-cause analyses and implement CAPAs.
• Approve Deviations and CAPAs.
• Technical Expert & Problem Solver: guide Assembly/Packaging and monitor trends.
• Inspection support: assist regulatory inspections and dossier reviews.
• Compliance: risk assessments and change controls.
• Manufacturing Process Oversight: oversee assembly, labeling, serialization and warehouse ops.
• Digital Footprint: QA owner for digital shop-floor applications.

Job description

Genentech in Holly Springs, NC seeks a Principal QA Specialist with extensive GxP experience to ensure quality for Assembly, Packaging and Warehouse operations.

You will lead quality oversight, drive continuous improvement, collaborate with MSAT, Operations, and Global teams, and embed Quality by Design into site processes while supporting regulatory readiness and CAPA/Deviations approval.