Senior Manager, Data Integrity

**377563BR** **Job ID:** 377563BR **About the role:** Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine. Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE). 36 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! The Senior Manager, Data Integrity, responsibility is to drive awareness and change management activities at the site level necessary to ensure a culture of Data Integrity Excellence. Responsibilities include but not limited to: • Establishes and managers all site Data Integrity topics. • Assures appropriate systems and processes to support GxP data integrity. Drives and monitors site progress against the Data Integrity Plan, oversee site implementation of corrective and preventive measures (CAPAs) and related mitigation of risks. • 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. •Continuously improve data integrity knowledge base and understanding: Identify training needs and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training. •Creates and participates in design and delivery of activities to engage shop floor associates in strengthening quality culture, leveraging network of functional DI SMEs/DI Champions. •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. • Ensures sharing of practices and alignment within stakeholders on key DI topics. Manages/Leads DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties. • Supports preparation for regulatory/health authority inspections and/or response development for DI related topics. 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. The pay range for this position at commencement of employment is expected to be between $97,600 and $146,400 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Job Description\n\n\n\n **Position Title:** Senior Manager, Data Integrity **Role Requirements:** Education: BS in business or life sciences; higher level degree for example MS, MBA preferred. Experience: 10 years’ experience supporting manufacturing, quality, and contract supplier/customer interactions; BLA/MAA and PAI experience preferred. 5 years of direct industry Data Integrity related experience. Experience working in a diverse global SME matrix environment, with ability to drive and manage change. Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, pre-clinical 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. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills. Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain. Knowledge and understanding of cGXPs NOTE: Approximately 15% travel required. Why Advanced Accelerator Applications? Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. **Job Type:** Full Time **Country:** USA **Work Location:** Indianapolis, IN **Functional Area:** Quality **Division:** Operations **Business Unit:** QUALITY **Employment Type:** Regular **Company/Legal Entity:** AAA USA Inc. **Commitment to Diversity & Inclusion::** _The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._ **Shift Work:** No **Early Talent:** No