Details

Contract

Full-Time

Location

Stamford CT, United States

Department

Life Sciences

Openings

1

Job ID

53520499

Quality Risk & Compliance Manager - Stamford, CT 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. We are excited that our US headquarters in NYC has moved to Stamford, Connecticut as of November 2022. Our beautiful new location is just steps away from the Stamford Metro-North Train Station and easily accessible from NYC. Your ‘day to day’: In this role, you will provide strategic leadership and a proactive approach to identifying, evaluating, and mitigating US Marketed Product-related Regulatory and Quality Management risks to prevent or mitigate failures with related laws & regulations, internal product standards, and/or meeting consumer expectations. You will drive a culture of commitment to Compliance by being a role model with an independent and influential voice and holding leaders at all levels to responsible standards. This is a US-based role that will work across US, EU, & Asia regions, PMI Senior Leaders, internal Subject Matter Experts (SMEs) and external Industry Advisors. The role will facilitate discussions related to Major and Critical Regulatory and Quality Management Risks across R&D and the global manufacturing & supply chain to ensure the risks are calibrated and escalated in a timely and rigorous manner. More specifically, you'll • Team: Lead and build risk management strategy and capabilities across PMI and in all relevant international standards and regulatory requirements. (i.e ISO/GxP/ICH/FDA) Collaborate with corporate audit team • Quality Compliance Expert/SME: Quality/compliance leadership and expertise to provide consultative support to teams with quality/compliance-related questions/concerns and/or those requiring assistance to resolve an historical/ongoing problem. • Quality Risk Assessment & Monitoring Plan: Responsible to assess and 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: Drives 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: Plan, communicate and execute internal Quality Compliance monitoring & mock inspections according to plan. Share cross-site learnings and continually improve PMIs global Quality/Compliance performance. • Quality Management System (QMS): Strategic insights, root cause analysis, and improvements to QMS to ensure effective deployment, and for building PMI quality culture and capabilities. Communicate across the relevant business and partners impacting quality compliance related issues and risks Mentor and guide collaborators on ISO/GxP/ICH/FDA. • Learning: Accountable to ensure that findings from audits, inspections, and internal reviews, are strategically translated into positively framed concrete feedback to drive improvement. Who we’re looking for • Proven experience in Quality Assurance in pharmaceutical, dietary supplements, medical device industries • Confirmed working experience in GXP environment, in relevant international organizations • Proven 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 • 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 • Legally authorized to work in the U.S. Annual Base Salary Range: $138,000 - $190,000 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: To improve the lives of a billion smokers. 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. #LIjobs

Apply