Manager, Technical Compliance and Data Integrity Lead

Job Description Summary

Manager, Technical Compliance supports the Data Integrity program, quality risk management, KPIs, continuous improvement, and quality engineering/QA IT at the Gene Therapies NC site.

Durham, NC – hybrid schedule.

• Manage a team overseeing quality engineering and QA IT.
• Ensure on-time delivery of compliance activities related to QA IT and Quality Engineering.
• Lead regulatory CMC launches and post-approval activities, ensuring timely supply to markets.
• Maintain and monitor the Quality Risk Management Program.
• Drive Data Integrity culture through program implementation and monitoring.
• Serve as site subject matter expert for DI inquiries, trainings, and assessment tools.
• Identify DI SMEs and DI Champions network.
• Collaborate with DI SMEs to strengthen DI culture through behavioral change management.
• Drive continuous improvement in detecting and mitigating DI risk.
• Lead DI topics in investigations, alerts, audits.
• Facilitate identification of high-risk data processes and systems.
• Champion mid‑ and long‑term actions to reduce DI risk.
• Implement DI tools, training materials, and guidance.
• Support QA approval of quality management records.

• BSc in Chemistry, Biology, Pharmacy, business, or related experience.
• Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred.
• 10 years’ experience in Quality Systems, Quality / Regulatory Compliance, operational GxP areas, Quality Control/Assurance, Supplier Quality, and/or Post Market Quality within pharma, diagnostics, or medical devices. Experience in advanced therapies preferred.
• Industry Data Integrity experience. Aseptic manufacturing experience preferred.
• Cross‑functional experience in a GxP regulated pharmaceutical industry (Q Assurance) and other qualified operations, with strong regulatory background.
• Knowledge of applicable cGMP regulations, FDA, ICH, EU, ISO standards.
• Strong experience supporting DI programs, risk analysis, project management, budgeting, communication, presentation.
• Prior experience leading health authority audits/inspections.
• Experience working in a diverse, fast‑paced, global SME matrix environment, driving and managing change.

Competitive salary range $108,500–$201,500, performance‑based cash incentive, potential equity awards. Comprehensive health, life, disability, 401(k) match, travel, vacation, holidays, and other leaves.

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

We are committed to working with individuals with disabilities and providing reasonable accommodation. If you need a reasonable accommodation throughout the application process or to perform essential functions of the position, contact us sonab or call . Include the job requisition number in your message.

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• Agility, Business Acumen, Collaboration, Communication, Continual Learning, Decision Making, Employee Performance, GMP Procedures, Goal Orientation, Health Authorities, Leadership, Logical Thinking, People Management, Problem Solving, QA, Self Awareness, Smart Risk Taking, SOP (Standard Operating Procedure), Technological Expertise.