Manager, Technical Compliance and Data Integrity Lead

Manager, Technical Compliance and Data Integrity Lead

The Manager, Technical Compliance, is responsible for all aspects of the Gene Therapies North Carolina Site Data Integrity Program, including creation, implementation, defining, monitoring and reporting KPIs, crafting solutions for KPI improvement, and continuous program improvement. The manager also maintains and monitors the quality risk management program encompassing Quality Engineering, QA IT, and CMC Facilitation, and serves as the Data Integrity Lead for the GTxNC site.

Durham, NC (hybrid schedule).

• Manages a team that oversees quality engineering, QA IT, and CMC Facilitation.
• Ensures on‑time delivery of compliance activities related to QA IT and Quality Engineering.
• Manages staff responsible for regulatory CMC launches and post‑approval activities (post‑approval changes, transfers, remediation, divestment, pruning, and due diligence) to ensure timely supply in compliance with regulations.
• Maintains and monitors the Quality Risk Management Program.
• Drives a Data Integrity culture through implementation and monitoring of the Data Integrity program.
• Serves as the site subject‑matter expert for all DI inquiries, trainings, and assessment tools.
• Maintains a network of DI Subject Matter Experts and Champions within GxP functional areas.
• Determines strategy and collaborates with DI SMEs/Champions to drive behavioral change that strengthens DI culture.
• Drives continuous improvement in detecting and mitigating DI risk by embedding DI focus into existing site programs.
• Leads DI topics at site in investigations, rapid alerts, reviews, and audits related to Data Integrity for internal and external parties.
• Facilitates identification of high‑risk data processes and systems via risk assessment, gap assessment, and data mapping.
• Identifies and champions opportunities for mid‑ and long‑term actions to reduce DI risk.
• Implements DI tools, training materials, and guidance at the site according to defined strategy.
• Supports QA approval of quality management records for the QA quality systems team.

• BSc in Chemistry, Biology, Pharmacy, business, or related experience.
• Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or a scientific discipline preferred.
• Manages a team of 4+ employees.
• 10 years’ experience in Quality Systems, Quality / Regulatory Compliance, or operational GxP areas (Manufacturing / Development), Quality Control, QA, Supplier Quality, or Post‑Market Quality in the pharmaceutical, diagnostic, or medical device industries; experience in advanced therapies (CGT, RLT, etc) preferred.
• 5 years’ experience with industry Data Integrity; prior experience with aseptic manufacturing preferred.
• Cross‑functional experience in a GxP‑regulated pharmaceutical industry (e.g., QA, clinical operations, PV, preclinical operations). Strong operational background preferred.
• Knowledge of applicable cGMP regulations (e.g., FDA 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, EU regulations, ISO Standards. Strong experience in supporting DI programs, risk analysis, project management, budgeting, communication, and presentation.
• Prior experience leading Health Authority Audits / Inspections, including front room/back room readiness and response to findings.

The salary for this position ranges between $132,300 and $245,700 annually. Final salary will be determined based on relevant skills and experience and may be reviewed periodically. The role includes a performance‑based cash incentive and eligibility for annual equity awards. US‑based employees are eligible for a comprehensive benefits package, including health, life and disability benefits, a 401(k) with company contribution and match, and generous time‑off and holiday policies.

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other, we combine to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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