Principal Quality Compliance Strategist – Digital GMP

Genentech, Inc.; Holly Springs (NC); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, North Carolina seeks a Principal Quality Compliance Specialist to lead a portfolio of strategic quality initiatives and champion digital regulatory compliance. This role anchors the Quality Management System and partners with Operations, MSAT, QA, QC, and global leaders to embed risk-based quality culture across the site.

Relocation assistance is available, and the position supports continuous improvement and operational excellence in aseptic drug product

Qualifications

• 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.

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.

Job description

Genentech in Holly Springs, North Carolina seeks a Principal Quality Compliance Specialist to lead a portfolio of strategic quality initiatives and champion digital regulatory compliance. This role anchors the Quality Management System and partners with Operations, MSAT, QA, QC, and global leaders to embed risk-based quality culture across the site.

Relocation assistance is available, and the position supports continuous improvement and operational excellence in aseptic drug product