Details

Contract

Full-Time

Location

New York, United States

Department

Operations

Openings

1

Job ID

51635081

GxP Risk Manager 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. Wherever you join our crucial 47,000-strong Operations team, you’ll have the opportunity to make an impact. PMI’s shift from selling cigarettes to our new smoke-free products has changed the way we work. New products bring new challenges – in the way we source and buy raw materials, in the way we engineer and manufacture, and in our supply chain planning. Bring us your curiosity and a desire to challenge the everyday and we’ll give you lots of responsibility. You’ll help us improve, inject innovation and create new ways of working. You’ll be solving supply chain problems that span the whole world: a smoke-free world. We are excited that our New York Corporate headquarters will move to southwest Connecticut in summer 2022. Our new location would be within easy access to New York City. We have implemented Smart Work, which is a hybrid model of working from home and office, and it will allow our employees to continue working from home certain number of days per week.” Your ‘day to day’ • Quality Compliance Oversight-Collaborate with Corporate Quality Team and Product Quality Team to provide Quality Compliance oversight. • Compliance Expert/SME-Contribute to provide expertise, interpretation and guidance related to relevant international standards, regulatory requirements, and guidelines to drive compliance. • Risk Assessment & Monitoring Plan-Responsible to establish risk-based assessment of PMI entities under the umbrella of QMS. Contribute to derive and establish monitoring plan. Contributes to reassess plan quarterly and to adjust with PMI strategy to anticipate new forthcoming requirements. • Inspection Readiness-Implements the vision for inspection readiness through proactive internal reviews, providing teams with support to resolve obstacles to process adherence and well documented training delivered by SMEs and other qualified instructors, performance of mock inspections. • Monitoring Activities-Plans, communicates, and oversights internal Quality Compliance monitoring & mock inspections according to plan. Constantly monitor and update heat map risk register, in line with business evolution and mock inspections feedback. • Support to Quality Management System- Supports strategic changes to the PMI Quality Management System to ensure compliance to GxPs and industry standards. Communicate across the relevant business and stakeholders impacting quality compliance related issues and risks. • Quality Compliance Governance Forums-Provide support to preparation and follow up of applicable quality governance forums for escalation of quality and compliance risks to drive resolution Who we’re looking for • Bachelor’s Degree in Engineering, Chemistry or related field • 10 years working experience in Quality Assurance in pharmaceutical industries or medical device industries • 10 - 15 years working experience in GXP environment in pharmaceutical industries or medical device industries • 5 years working experience in Quality Risk Management • Profound knowledge in US GXP and EU regulations relevant for audit/inspections, qualification/validation, compliance systems • Excellent communication and decision making skills • Proficient in providing solutions for complex challenges • Good problem analysis and problem solving with quality tools • Ability to work independently in a team environment • Past experience in working within a cross-functional, multidisciplinary and project team oriented environment to ensure project and business alignment • Highly collaborative, integrator, strong communicator and influencer holding very good business awareness • Creativity and fact based analytical skills • Technical writing skills, ability to communicate technical knowledge in a clear and understandable manner • Fluent in English, both written and spoken What we offer Our success depends on our talented employees who come to work here 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 deliver a smoke-free future. PMI is an Equal Opportunity Employer PMI Global Services Inc. is 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 March 31, 2021, PMI's smoke-free products are available for sale in 66 markets in key cities or nationwide, and PMI estimates that approximately 14.0 million adults around the world have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.

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