Manager, Technical Compliance and Data Integrity Lead

Role Summary

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, creating solutions for KPI improvement and continuous improvement of the program. In addition, the Manager is responsible for the maintenance and monitoring of that quality risk management program, Quality Engineering, QA IT, and CMC Facilitation. The manager will also be responsible for being the Data Integrity Lead for the GTxNC site.

Responsibilities

• Manages a team that oversees quality engineering, QA IT and CMC Facilitation.
• Manages the team to ensure on time delivery of compliance activities related to QA IT and Quality Engineering.
• Manages the staff responsible for the regulatory CMC related launches and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements
• Maintenance and Monitoring of the Quality Risk Management Program
• Proactively drives establishment of Data Integrity culture through implementation and monitoring of the Data Integrity program.
• Serves as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools.
• Identifies and maintains a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.).
• Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture.
• Drives continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc.
• Manages/Leads DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties.
• Facilitates the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.).
• Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk.
• Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy.
• Responsible for supporting QA approval of quality management records for the QA quality systems team.

Qualifications

• BSc in Chemistry, Biology, Pharmacy, business, or related experience.
• Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred.
• Manages a team of 4+ employees.
• 10 years‚Äô experience in Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Quality Control, Quality Assurance, Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries. Experience in advanced therapies (CGT, RLT, etc) is preferred.
• 5 years‚Äô of industry Data Integrity related experience. Prior experience with aseptic manufacturing is preferred.
• Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, preclinical operations, manufacturing/engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21CFR Part 11 requirements. Strong operational background preferred.
• Knowledge of applicable cGMP regulations, for example, FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills.
• Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations.

Skills

• Quality risk management
• Data integrity programs
• Regulatory compliance and GxP knowledge
• Leadership and team management
• Risk assessment, data mapping, and audit trail review
• Project management and cross-functional collaboration