Senior Principal Quality Control Specialist, Master Data

About the Role

Welcome to Holly Springs, North Carolina—home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams, and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility leverages advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes to produce high-quality medicines for Cardiovascular, Renal, and Metabolism (CVRM) conditions, with a focus on next-generation metabolic medicines targeting the global obesity epidemic and Type 2 diabetes.

This is a fast-paced, entrepreneurial environment with a high level of accountability, with a planned launch in 2028. The Holly Springs QC Team is seeking an individual to create and sustain a fully digital QC laboratory, focusing on simple to moderately complex sets of Master Data that support QC operations. This role collaborates with internal and external departments (e.g., QC Operations, Database System Developers, Business Analysts, Manufacturing, Packaging, External Quality, Control System Scientists, Product Technical Leads) to maintain and improve the contemporary relevance of QC Master Data.

Responsibilities

• Develop and deliver end-user training for QC IT systems as a key subject matter expert.
• Own deviation investigations, Corrective and Preventive Actions (CAPAs), Change Requests, periodic reporting, system evaluations, audit trail reviews, and analytical equipment administration.
• Create, update, and test Master Data and end-user defined system settings to enable consistent execution, collection, transaction, storage, analysis, and reporting of QC data.
• Serve as the site representative on System Enhancement and User Communities of Practice Teams, communicating system changes and best practices to local system users.
• Lead or participate in Quality Control Investigations using established Root Cause Analysis tools and generate data-based impact assessments within established timelines.
• Own Corrective and Preventive Action Plans and Change Controls.
• Author, review, and/or approve standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments.
• Participate in cross-functional teams to ensure safety, quality, delivery, engagement, and cost objectives are sustained or exceeded.

Requirements

• B.S./B.A. degree in Chemistry, Biochemistry, or a relevant scientific discipline.
• Minimum of eight years of experience in a GMP setting.
• Proven experience building and maintaining complex static data (Specifications, Methods, Sampling Plans) in a production environment.
• Working understanding of database management/relational tables, preferably with experience in Labware (LIMS), Binova (LES), SAP, Mettler Toledo LabX, Waters Empower Chromatography Data System, or similar cGMP QC systems.
• Sound knowledge of cGMPs or equivalent regulations.
• Ability to interpret and apply quality standards to operational activities.
• Strong verbal and written communication skills.

Work Environment

• On-site work in a flexible open-space environment and QC laboratories requiring gowning (lab coat, eye protection, gloves).
• Interaction with analytical instruments and computerized systems/screens for extended periods (6-8 hours).
• May be required to lift up to 25 lbs.
• May work with hazardous materials and chemicals.

Pay

The expected salary range for this position in Holly Springs, NC is $128,000 - $238,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the provided link. Note: There are no relocation benefits available for this position.