Principal Quality Compliance Specialist, CVRM (Holly Springs)

Genentech•Holly Springs, NC

6d•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 2028. 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 We seek a highly impactful Principal Quality Compliance Specialist who possesses extensive experience in quality, compliance, and project execution, combined with a strong risk-based operational focus. In this critical role, you will lead a portfolio of diverse, strategic quality initiatives and be the site expert on digital compliance. This facility will ensure the consistent manufacturing of high-quality products that meet global regulatory requirements and Roche's rigorous internal standards. As a Principal Quality Compliance Specialist, you will serve as the foundational compliance anchor and strategic project leader within our Quality Compliance team. You will play a vital role in embedding a robust, risk-based Quality Management System (QMS) across the site while championing continuous improvement initiatives that span local operations and global networks. 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.

Requirements

Bachelor's degree in a scientific/technical discipline (Advanced degree preferred).
Minimum 8–10 years in a GxP environment, with at least 4 years leading strategic quality improvement projects in manufacturing and/or QC environments.
Deep expertise in global GxP regulations (FDA, EMA, ICH, ISO) and their application in digital, sterile manufacturing and device packaging environments.
Extensive experience assessing Annex 4 and Annex 11 compliance in highly automated environments.
Proven ability to translate Data Integrity and QRM methodologies into robust operational controls for drug and combination products.
Experience with defining controls and governance associated with the use of Artificial Intelligence (Annex 22) preferred.
Track record of leading cross-functional teams to deliver strategic quality improvements.
Demonstrated success developing, implementing, or auditing site-wide Data Integrity programs within highly automated or digital footprints.
Broad experience across Quality and operations preferred.
Extensive experience with regulatory inspections and health authority interactions.
Strong collaborator skilled at proactively communicating quality risk and fostering a transparent, solution-oriented culture.
Exceptional ability to influence stakeholders, site teams, and global leaders without formal authority.
Thrives in ambiguity, challenges the status quo, and leverages Lean/Six Sigma to drive operational rigor.
Adaptable in dynamic, fast-paced environments while maintaining high-quality and safety standards.

Responsibilities

Lead Strategic Quality Projects: Act as the primary site liaison for global compliance trends, knowledge sharing, and improvement initiatives.
Execute strategic Global Quality projects by translating network mandates into actionable project plans.
Develop and oversee local implementation strategies, ensuring alignment with project timelines.
Drive strategic site quality improvement initiatives to enhance operational performance.
Coordinate and lead targeted deep-dive assessments and complex risk assessments.
Apply QRM methodologies to translate risks into sustainable operational controls.
Provide subject matter expertise and support for critical site projects as required.
Cross-Functional Collaboration: Partner cross-functionally (Operations, MSAT, QA, QC, Engineering) and with global leaders to harmonize standards and drive transformation.
Provide technical and organizational leadership to foster a proactive, risk-based quality culture.
Mentor and upskill the organization to enhance self-identification of risks and promote a culture of proactive issue resolution.
Core Quality Compliance Support Serve as the site Subject Matter Expert (SME) for digital regulatory requirements and inspection commitments, assessing compliance status and leading remediation action plans.
Provide support to core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
Support key compliance processes, including Quality Escalations, Recalls, Inspection Management, Self-Inspections, Site Master File, Management Reviews, Supplier Management, and Health Authority engagement.