Risk Manager Quality Compliance

Risk Manager Quality Compliance – Hong Kong 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. 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 help accelerate the end of cigarettes. Your ‘day to day’ You will be employed in Hong Kong under Philip Morris Asia Limited (PMAL). PMAL operates as a subsidiary of Philip Morris International, Inc. You will support the Quality Compliance Group, deliver an independent quality compliance oversight to ensure adherence to national and international regulations, PMI quality management system (QMS), and contractual agreements, plan and implement a risk based review of functions, processes, sites/locations in scope, oversee reviews preparation for certification inspections by regulatory authorities, constantly check and update heat map risk register, in line with business evolution and mock inspections feedback, support strategic changes to the PMI Quality Management System to ensure compliance to GxPs and industry standards, provide support to preparation and follow up of applicable quality governance forums to raise quality and compliance risks and drive resolution. More specifically you will: • Ensure Quality Compliance oversight and collaborate with Corporate Quality Team and Product Quality Team • Be the Compliance Specialist/SME and contribute to provide expertise, interpretation and guidance related to relevant international standards, regulatory requirements to drive compliance • Be responsible for Risk Assessment & Monitoring Plan, 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 • Implement 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 • Monitor Activities Plans, communicate and oversee internal Quality Compliance monitoring & mock inspections according to plan. Constantly check and update heat map risk register, in line with business evolution and mock inspections feedback • Provide Quality Management System Support regarding strategic changes to the PMI Quality Management System to ensure compliance to GxPs and industry standards. Communicate across the relevant business and teams impacting quality compliance related issues and risks • Provide support to preparation and follow up of applicable Quality Governance Forums to raise quality and compliance risks to drive resolution Who we’re looking for • Bachelor’s Degree in Engineering, Chemistry or related field • Substantial working experience in Quality Assurance, GxP environment, in Quality Risk Management in pharmaceutical or medical device industries • 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, within a cross-functional/multidisciplinary/project team oriented environment to ensure project and business alignment. Highly collaborative, integrator, strong influencer holding very good business awareness. Sound 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. #LI-Hybrid