Validation Lead

Validation Lead – Wilson, North Carolina Be a part of a revolutionary change At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Our success depends on people who are committed to our purpose and have an appetite for progress. As a Validation Lead, you will lead PMI’s computerized system validation project approach and establish the validation strategy of computerized systems, including assessment and delivery of all validation deliverables. You ensure validation maintenance of GxP systems within your defined scope. You will also ensure the training of project team members and users of the system in the context of computerized systems validation and data integrity. Your specific responsibilities will be: • Define, document and maintain the risk assessments for implementation of new systems and changes to existing GxP systems to support a risk-based validation approach • Establish validation plans (including CSV Strategy) & validation reports of different projects • Perform QA Review of validation deliverables • Manage QA Review of Data governance documentation • Participate in the development and improvement of QMS procedures and practices for data integrity and CSV • Advise project managers and IS system service managers on validation activities in a timely manner • Train and coach on the validation and DI strategy as well as practices related to CSV and DI • Support Latin America, US and Canada affiliates for the validation of manufacturing core standard systems. Who we’re looking for: • University degree in Engineering or Science or equivalent • Information System and business experience would be an asset • Solid understanding of regulated life sciences industry processes (deep knowledge of CFR21 Part 11, Annex 11, GAMP5, etc.) from early research to industrial manufacturing (process mapping, data governance and architecture, traceability). • Proven CSV experience (5+ years) in a regulated environment, such as Life Sciences • At least 2+ years’ experience leading validation of GxP systems in a regulated life sciences industry • Experience in writing and reviewing validation deliverables related to CSV of GxP systems • Strong problem solving, solid communication and interpersonal abilities as well as proven leadership and organizational savvy • Excellent communication skills and fluency in English, French would be an asset • Legally authorized to work in the U.S.. What we offer • We offer a competitive base salary, annual bonus (applicable based on level of position), great medical, dental and vision coverage, 401k with a generous company match, incredible wellness benefits, commuter benefits, pet insurance, generous PTO, and much more! • We have implemented Smart Work, a hybrid model of working that promotes flexibility in the workplace. • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture where everyone’s contribution is respected; Collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: a smoke-free future. PMI is an Equal Opportunity Employer PMI Global Services Inc. and PM Global Brands Inc. are a subsidiary of Philip Morris International Inc. Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products, associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the U.S., where these products have received marketing authorizations from the U.S. Food and Drug Administration (FDA) under the premarket tobacco product application (PMTA) pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a Modified Risk Tobacco Product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of September 30, 2022, PMI's smoke-free products are available for sale in 70 markets in key cities or nationwide, and PMI estimates that approximately 13.5 million adults around the world, excluding Russia and Ukraine have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com. #LI-Hybrid