Full-Time
Manager – Technical Compliance and Data Integrity Lead
Posted on 1/18/2026
Novartis
10,001+ employees
Global pharmaceutical company delivering science-based innovations
Compensation Overview
$114.1k - $211.9k/yr
Durham, NC, USA
Hybrid
 Biology & Biotech (2) |
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- 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 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.
- Experience with 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.
- Experience working in a diverse, fast-paced, local and global SME matrix environment, with ability to drive and manage change.
- 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.
- Agility
- Business Acumen
- Business Partnering
- Collaboration / Teamwork
- Communication Skills
- Continued Learning
- Dealing With Ambiguity
- Decision Making Skills
- Employee Performance Evaluations
- Gmp Procedures
- Goal-Oriented
- Health Authorities
- Leadership
- Logical Thinking
- People Management
- Problem Solving Skill
- Problem Solving Skills
- Qa (Quality Assurance)
- Self-Awareness
- Smart Risk Taking
- Sop (Standard Operating Procedure)
- Technological Expertise
Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.
Company Size
10,001+
Company Stage
IPO
Headquarters
Basel, Switzerland
Founded
1970
Your Connections
People at Novartis who can refer or advise you
Simplify's Take
What believers are saying
- Acquiring Avidity Biosciences added three late-stage genetic therapies to its neuroscience pipeline.
- Partnering with Impact Stewards accelerates heart failure guideline adoption across six Dutch hospitals.
- Collaborating with Howard University strengthens clinical trial access for underrepresented communities.
What critics are saying
- Large external deals like Orionis risk pipeline dilution if molecular glue programs fail within 12–24 months.
- The $12 billion Avidity purchase creates knock-out risk if genetic therapies miss regulatory expectations.
- Rapid acquisition of Excellergy, Pikavation, and Relation strains integration and capital allocation.
What makes Novartis unique
- Novartis focuses exclusively on innovative medicines after spinning off Sandoz in October 2023.
- The company leads molecular glue R&D via its expanded Orionis collaboration worth up to $1.4 billion.
- Novartis merges AI-driven discovery with functional genomics to uncover novel targets for allergic diseases.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Vacation
Paid Sick Leave
Paid Holidays
Hybrid Work Options
Growth & Insights and Company News
6 month growth
↑ 2%1 year growth
↑ 2%2 year growth
↑ 2%Rewrite this news in-house style based on British English without Plagiarism, remove direct speeches, and Use simple and uncomplicated language as far as possible. Thursday, June 11, 2026 Orionis Biosciences has entered into an expanded multi-year collaboration with Novartis to discover and develop molecular glue medicines targeting difficult-to-treat diseases across multiple therapeutic areas. The agreement builds on the existing relationship between the two companies and aims to advance the use of induced proximity approaches in drug discovery. Under the collaboration, Orionis and Novartis will use Orionis's Allo-Glue(TM) platform together with its artificial intelligence-driven discovery engine to accelerate target identification, ligase profiling and molecular glue optimisation. The combined technologies are designed to support the systematic discovery of small-molecule molecular glues, which work by bringing proteins into close proximity to modify biological processes and influence disease-related targets. As part of the agreement, Orionis will receive an upfront payment of USD 40 million. The company is also eligible to receive up to USD 1.4 billion in research, development and commercial milestone payments, in addition to tiered royalties on future product sales arising from the collaboration. The expanded partnership reflects continued confidence in Orionis's molecular glue platform and its progress in developing scalable and rational approaches for discovering this emerging class of medicines. Orionis noted that recent advances in artificial intelligence and robotic automation have improved several stages of molecular glue discovery, including identifying productive target-ligase pairs and optimising potential drug candidates. These developments have helped strengthen the platform's capabilities and support larger collaborative programmes. The companies will explore the potential of molecular glue technologies across a range of therapeutic areas, with the goal of expanding the number of biological targets that can be addressed through future treatments.
On Clinical Trials Day, Howard University emphasizes trust and participation in research. May 20, 2026 2 minutes May 20 is Clinical Trials Day, and Howard University is marking the observance through ongoing efforts to improve trust and participation in clinical studies for communities traditionally overlooked in the research process. According to Celia J. Maxwell, professor of medicine and director of Howard University's Clinical Trials Unit, the university is currently involved in approximately 13 clinical trials, including studies in startup and contracting phases. Howard University's clinical trials program has also been strengthened through collaborations with industry partners such as Novartis and Sanofi, which help expand access to research and emerging treatments. "Clinical trials are highly regulated and include strict protections around participant privacy and study integrity," Maxwell says. "They are essential because they help determine whether treatments are safe and effective across diverse populations." At Howard University, ongoing clinical trial studies span a wide range of conditions, including asthma, chronic obstructive pulmonary disease (COPD), Alzheimer's disease, eczema, hidradenitis suppurativa, chronic hives, heart disease, and chronic kidney disease. Maxwell said the goal is to expand access to emerging treatments while ensuring that communities most affected are represented in medical research. Historically, African Americans and other groups have been excluded from medical research, contributing to lingering mistrust shaped in part by the infamous Tuskegee Study. Maxwell said modern clinical trials now operate under strict safeguards, including informed consent, federal oversight, and ongoing safety monitoring. In recent years, Howard University and Howard University Hospital have also worked to strengthen their clinical research infrastructure. Investments have included expanded staffing, pharmacy capabilities, data systems, and community outreach efforts designed to support long-term growth in clinical research. Maxwell noted several ways for Howard students and community members to become involved in clinical research. Individuals can learn about ongoing studies and opportunities through resources such as ClinicalTrials.gov, Howard University's Office of Regulatory Research Compliance, university outreach events, community health programs and fairs, training and mentorship opportunities, and CITI research training programs. She added that students interested in research careers can seek opportunities through faculty mentorship, clinical research training programs, internships, and volunteer experiences connected to ongoing studies. Observed globally each May 20, Clinical Trials Day recognizes the anniversary of what is considered the first randomized clinical trial, conducted in 1747 by British naval surgeon James Lind to study treatments for scurvy among sailors. Today, the observance also provides an opportunity to educate the public about the importance of clinical trials in advancing medicine and improving patient care. Jul 28, 2021 4 minutes Jun 22, 2022 4 minutes Are you a member of the media? Its public relations team can connect you with faculty experts and answer questions about Howard University news and events.
How can Impactstewards improve heart failure care? Heart failure is a serious condition with a significant impact on the daily lives of patients and their loved ones. Fortunately, over the past decade, there have been many advancements in heart failure care. However, understandably, these improvements have not yet been fully implemented everywhere in the Netherlands. This prompted Impact Stewards and Novartis to join forces. Impactstewards gathered insights from cardiologists at six hospitals and compiled them into the Practice Paper: Heart Failure Care of the Future. Why improving heart failure care doesn't happen automatically. Developments in heart failure care have advanced rapidly over the past ten years. New scientific insights, guidelines, home monitoring tools, and communication channels have emerged. Yet, implementing these improvements in heart failure care does not always take off smoothly. As a result, a patient may have a higher chance of receiving guideline-based treatment in one hospital compared to another. In the daily hustle of clinical care, it can be challenging for heart failure teams to address this systematically. Six hospitals share how they improve heart failure care. As a pharmaceutical company, Novartis is in contact with almost all cardiologists in the Netherlands. It asked Impact Stewards for help: Could Impactstewards collaborate to gather insights from centres with outstanding examples of innovative heart failure care? This way, cardiologists can learn from each other more quickly. In the Practice Paper: Heart Failure Care of the Future, Impactstewards compile insights from six hospitals. Cardiologists from Catharina Hospital, Maastricht UMC+, Pantein Maasziekenhuis, Rijnstate, Spaarne Gasthuis, and St. Antonius share their experiences. How have they implemented new guidelines and improved the accessibility and quality of cardiological care? And how are they preparing for the heart failure team of tomorrow? What does the future of heart failure care look like? Six hospitals share how they have structured their heart failure care. What does the future of heart failure care look like? The paper includes recommendations to improve heart failure care: * Rapidly achieving Optimal Medical Therapy (OMT) in an outpatient setting * Home monitoring and restructuring patient support * Developing a standardised and multidisciplinary care pathway * Facilitating and encouraging self-management * Gaining insights through data analysis of the patient population * Optimal collaboration within the heart failure team The Practice Paper: Heart Failure Care of the Future is now available to healthcare providers via Novartis: "We created a Practice Paper with examples from six centres, showing how they improve heart failure care. By learning from others, you can implement these improvements faster." - Naomi Tielen, Impact Steward How Impact Stewards contributes. Impact Stewards helps organisations in healthcare and life sciences do better - for patients and the planet. Its mission is to improve the accessibility, affordability, and sustainability of its healthcare system. Its Impact Stewards are seasoned experts in healthcare and life sciences. Together, Impactstewards oversee the entire healthcare system: from medical innovation to patient care. Impactstewards leverage its sector knowledge, advisory skills, and transformation expertise to achieve sustainable change. In this project, Impact Stewards serves as an independent partner. Impactstewards represent the interests of all stakeholders and ensure the neutrality, transparency, and diligence of the process, decision-making, and outcomes as described in this Practice Paper.
Novartis Romania hires Alexandra Banas as Head of Legal. * Saida Ayupova * May 8, 2026 Alexandra Banas has joined Novartis Romania as its Head of Legal. Prior to joining the pharmaceutical company, Banas was the Head of Legal & Compliance SEE at Reckitt between 2020 and 2025. Before moving in-house, she worked as a Lawyer at GPA Law between 2018 and 2020, at Vernon | David between 2016 and 2018, at Fatu & Asociatii between 2014 and 2016, and at JGV si Asociatii between 2008 and 2012. "Alexandra joins us as Legal Head and brings with her a solid experience in legal strategy, compliance, and business partnership," a company statement read. "She strongly believes in collaboration and in supporting teams to perform, and we are glad to have her by our side!" Get the memo - every week. Essential in-house updates, straight to your inbox. * Saida Ayupova * May 14, 2026 Pobric joined the bank in 2024 as the Head of the Legal Affairs Department. Prior to ZiraatBank BH, she spent nine years at BBI Bosna Bank International. * Radu Cotarcea * May 11, 2026 Karanikola joins the telecommunications company from Ademu, where she was a Chief Operating and Legal Officer between 2024 and 2026. * Radu Cotarcea * May 6, 2026 Danielova joined the real estate company in 2023 as an Attorney. Earlier, she worked as a Lawyer at UniCredit Bank Czech Republic and Slovakia between 2019 and 2022.
Novartis closes factory in Wehr: 220 jobs cut. Pharma giant in Wehr Novartis closes factory near Swiss border - 220 jobs affected. The Swiss pharma giant is closing its production site in the southern German town of Wehr. It is no longer competitive. Published: 05.05.2026, 12:05 Swiss pharmaceutical giant Novartis plans to close its production site in Wehr, Baden-Württemberg, by the end of 2028. The Basel-based company announced that around 220 jobs would be cut. The reason for the decision: the site in the Waldshut district is no longer competitive. "We are aware of the uncertainty this announcement brings for our colleagues at the Wehr site," said production chief Steffen Lang. The company wants to work transparently and respectfully with employees and the municipality of Wehr. The Wehr site currently produces tablets and capsules. Novartis stressed that patient supply would not be endangered by the closure. The company reaffirmed its commitment to Germany as a location. At the same time, Novartis is investing 35 million euros in a new production facility for cancer therapies in Halle, Saxony-Anhalt, which is scheduled to start operations in 2027. According to its own information, Novartis employs over 2,600 people at six sites in Germany. Economy today Get the most important news from the economy, along with the best background information and analyses. More newsletters