Principal Quality Compliance Specialist, CVRM (Holly Springs)

About the role

Roche/Genentech is seeking a Principal Quality Compliance Specialist for its new Holly Springs, North Carolina facility, a $2B greenfield plant producing cardiovascular, renal and metabolism (CVRM) medicines. The role leads a portfolio of strategic quality initiatives and acts as the site's expert on digital compliance, embedding a risk-based Quality Management System and a proactive quality culture. Relocation assistance is available.

Key responsibilities

• Lead strategic quality projects: act as the site liaison for global compliance trends, turn network mandates into project plans, develop local implementation strategies and coordinate deep-dive and risk assessments using QRM methodologies.
• Partner cross-functionally with Operations, MSAT, QA, QC and Engineering, and mentor the organization to identify risks early.
• Serve as the site SME for digital regulatory requirements and inspection commitments, leading remediation action plans.
• Support core compliance processes such as Quality Escalations, Recalls, Inspection Management, Self-Inspections, Site Master File, Management Reviews, Supplier Management and Health Authority engagement.

Required profile

• Bachelor's degree in a scientific or 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.
• Proven track record of leading cross-functional teams and delivering site-wide Data Integrity programs.
• Extensive experience with regulatory inspections and health authority interactions; broad experience across Quality and operations preferred.

Required skills

• Deep expertise in global GxP regulations (FDA, EMA, ICH, ISO) in digital, sterile manufacturing and device packaging.
• Experience assessing Annex 4 and Annex 11 compliance in highly automated environments.
• Ability to translate Data Integrity and QRM into operational controls; experience with AI controls (Annex 22) preferred.
• Strong stakeholder influence and collaboration without formal authority.

The expected salary range for this position in Holly Springs, North Carolina is $114,700 - $212,900, depending on experience and qualifications; a discretionary annual bonus may be available.