Novartis · 2 weeks ago
Manager, Technical Compliance and Data Integrity Lead
Durham, NC
Full-time
Hybrid
Senior Level, Lead/Staff
$108K/yr - $202K/yr
10+ years expNovartis is a leading global healthcare company, and they are seeking a Manager, Technical Compliance and Data Integrity Lead. The role involves supporting the Data Integrity Program and quality risk management at the Gene Therapies North Carolina Site, managing a team, and ensuring compliance with regulatory obligations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Manages a team that oversees quality engineering and QA IT
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
Supporting the Maintenance and Monitoring of the Quality Risk Management Program
Assists the DI Lead with 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
Qualification
Required
BSc in Chemistry, Biology, Pharmacy, business, or related experience
10 years' 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 with of industry Data Integrity related experience
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
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
Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations
Experience working in a diverse, fast-paced, local and global SME matrix environment, with ability to drive and manage change
Preferred
Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline
Experience in advanced therapies (CGT, RLT, etc)
Prior experience with aseptic manufacturing
Strong operational background
Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills
Benefits
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-11
Morningstar.com
2026-01-11
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