Details

Contract

Full-Time

Location

Crespellano, Italy

Department

Life Sciences

Openings

1

Job ID

37481190

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 smoke-free products with the power to improve the lives of a billion smokers worldwide. We’re also exploring new categories, looking beyond nicotine to develop a new portfolio of innovative products. 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. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future, your work could change the lives of millions. Your ‘day to day’ As Manager IS Quality Governance and Data integrity you will lead, govern and oversight the end-to-end data integrity strategy, process and deployment. This includes to guide IT, engineering, Life Science and product team during process and change management regarding data integrity compliance requirements. Furthermore, you will manage, direct and empower the team in order to establish, maintain, document and govern data integrity process and tools. More specifically, you will: • Establish data maturity framework and data governance process for critical quality data • Advise 3rd party on CSV & DI requirements related to systems & process managing PMI critical data and ensure their adherence to PMI requirements. • Communicate during inspection with regulatory bodies on data integrity approach and risk management. • Ensure proper coordination and compliance of CSV & DI related to NC, CAPA, Deviation permits, changes and training. • Oversee Data governance of critical & master quality data by ensuring the data registration in global governance repository and liaise with PMI IT data governance team. • Lead the identification of master quality data of PMI critical records and document risk related data usage. • Manage and develop the validation team and coach them on soft, technical and functional skills. Who we're looking for • University degree in science, engineering or equivalent. • Seasoned experience in Validation and Computerized system compliance. IT and regulated business experience would be an asset. • Substantial experience working in regulated environment such as GCP, GLP and ISO 17025. • At ease with IT data governance, Product, Manufacturing, Life Science, and supply chain process. • Sound working knowledge of quality management system and process, data management, project management and SDLC. • Confirmed track record in leadership, ideally leading team in a matrix organization with validate ability to generate results and align organizational resources to accomplish strategic objectives. • Excellent communicator with the ability to communication at all levels of the organization, encourage direct and open discussions and solid client-facing capacity. • Proven ability to influence and coach, action driven and business acumen. • Fluent in English both oral and written. What we offer Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • 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: to improve the lives of a billion smokers.

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