Principal Quality Compliance Specialist, CVRM (Holly Springs)

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) diseases, with a focus on next-generation metabolic medicines targeting the global obesity epidemic and Type 2 diabetes. This fast-paced, entrepreneurial environment offers a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground up, shaping its culture and future.

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.

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.

Skills

• 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.

Benefits

Relocation assistance is available for this role.

Pay

The expected salary range for this position in Holly Springs, North Carolina is $114,700 - $212,900. 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.