Principal Validation Specialist, Quality Control

Roche•Holly Springs, NC

22h•Onsite

About The Position

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's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2029. Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine. The Opportunity In this exciting role, you will lead the site-level establishment, routine support, and continuous improvement of a "Best-in-Class" digital laboratory at our Holly Springs facility. As the primary technical lead, you will own the QC instrumentation validation lifecycle, firstly at laboratory start up leading to high throughput routine operations. In routine operations, you will own QC system management, change control, and technical support for the Holly Springs QC technology ecosystem to ensure a seamless, paperless, and “Data Integrity by Design” environment. You will be the QC System Owner and lifecycle management for test equipment and instrumentation. Author and review equipment/computer system lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Protocols, Reports Operational and Administration Procedures) You will serve as the site-level custodian for the creation, maintenance, and synchronization of all QC Master Data across the QC digital ecosystem. Configure and maintain instrument-specific master data to ensure seamless result transfer from raw data acquisition to the final execution layer. You will lead the integration of local laboratory instruments (HPLC, balance, pH meter,etc.) into global data management systems. You will monitor the performance of the integrated digital thread to ensure high-throughput testing remains uninterrupted and implement identified opportunities for continuous improvement. You will act as the on-site Subject Matter Expert (SME) to troubleshoot system glitches, interface errors, or instrument connectivity issues. You will coordinate with Local and Global IT for system patches, server maintenance, and version upgrades, ensuring minimal impact on lab operations. You will lead the site-level Change Control process for QC digital systems, ensuring that any modifications to methods or workflows are fully validated and documented. Own Quality System records relating to QC Equipment. You will manage the ongoing training and upskilling of QC users for system updates and digital best practices. You will act as the primary liaison between Holly Springs QC and Global IT/Automation teams. You will serve as a site representative on network-wide system validation teams formed to discuss emerging issues through resolution, and improve/standardize qualification of platform equipment. You will collaborate with Site Quality and Operations to ensure the digital QC landscape supports site-level operations. You will conduct and maintain comprehensive Data Integrity Assessments (DIA); establish robust audit trail review processes to ensure all QC data adheres to ALCOA+ principles. You will serve as the technical lead during regulatory inspections and internal audits for all matters related to QC electronic data, system security, and data integrity.

Requirements

Bachelor’s degree in Life Sciences (Chemistry, Biology, or Biochemistry), Computer Science/Information Technology or a related field
Minimum 4-7 years in a GMP data environment with a focus on QC digital systems.
Proven experience in lifecycle management of QC Digital systems.
Experienced in operating as SME in complex digital laboratory environments.
Proven experience building and maintaining complex static data (Specifications, Methods, Sampling Plans) in a production environment.
Performed Validation (IQ/OQ/PQ) of Quality Control Laboratory Instrumentation.
Experience performing formal Data Integrity assessments on computerized systems.
Deep understanding in ALCOA+, GAMP 5 and CFR 21 Part 11/Annex 11.
Excellent attention to detail and strong analytical problem-solving skills.
Experience presenting during regulatory, or internal inspections.
Strong communication and collaboration skills to work effectively with cross-functional teams.
Will be working on site in a flexible open space work environment and QC laboratories requiring gowning (lab coat, eye protection, gloves)
Will work on/interact with analytical instruments and computerized systems/screens for long periods of time (6-8 hours)
May be required to lift up to 25lbs
May have to work with hazardous materials and chemicals.

Nice To Haves

Administration experience in QC Software Applications.
Experience with the implementation of a Greenfield QC Laboratory

Responsibilities

Lead the site-level establishment, routine support, and continuous improvement of a "Best-in-Class" digital laboratory at our Holly Springs facility.
Own the QC instrumentation validation lifecycle, firstly at laboratory start up leading to high throughput routine operations.
Own QC system management, change control, and technical support for the Holly Springs QC technology ecosystem to ensure a seamless, paperless, and “Data Integrity by Design” environment.
QC System Owner and lifecycle management for test equipment and instrumentation.
Author and review equipment/computer system lifecycle documents (i.e. User Requirements Specifications, Data Integrity Assessments, Protocols, Reports Operational and Administration Procedures)
Serve as the site-level custodian for the creation, maintenance, and synchronization of all QC Master Data across the QC digital ecosystem.
Configure and maintain instrument-specific master data to ensure seamless result transfer from raw data acquisition to the final execution layer.
Lead the integration of local laboratory instruments (HPLC, balance, pH meter,etc.) into global data management systems.
Monitor the performance of the integrated digital thread to ensure high-throughput testing remains uninterrupted and implement identified opportunities for continuous improvement.
Act as the on-site Subject Matter Expert (SME) to troubleshoot system glitches, interface errors, or instrument connectivity issues.
Coordinate with Local and Global IT for system patches, server maintenance, and version upgrades, ensuring minimal impact on lab operations.
Lead the site-level Change Control process for QC digital systems, ensuring that any modifications to methods or workflows are fully validated and documented.
Own Quality System records relating to QC Equipment.
Manage the ongoing training and upskilling of QC users for system updates and digital best practices.
Act as the primary liaison between Holly Springs QC and Global IT/Automation teams.
Serve as a site representative on network-wide system validation teams formed to discuss emerging issues through resolution, and improve/standardize qualification of platform equipment.
Collaborate with Site Quality and Operations to ensure the digital QC landscape supports site-level operations.
Conduct and maintain comprehensive Data Integrity Assessments (DIA); establish robust audit trail review processes to ensure all QC data adheres to ALCOA+ principles.
Serve as the technical lead during regulatory inspections and internal audits for all matters related to QC electronic data, system security, and data integrity.