Senior Officer, Quality Assurance Compliance

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. for the Smoke-Free Products at electronic Product Development Center (ePDC). You will ensure effective deployment and application of the Quality Management System (QMS) concepts and tools for Electronic & Third Party Quality (TPQ), in line with Corporate QA requirements. Work closely with key suppliers (e.g. EMS) to role-model Quality at source, to pass any inspection/audit and continuously improve for compliance purpose. Coordinate corporate tools & systems in TPQ, collect and consolidate data and ensure effective use of them. Train end-users if need be. Responsibilities: • Ensure deployment of QMS concepts and tools within TPQ and critical suppliers and collect and maintain related data as per Corporate QA requirements. Raise appropriate change requests, prioritize required contributions and coordinate workflows in the system for efficient and smooth usage. • Ensure management review KPIs for the respective functions are understood, up-to-date and provided on time to senior management. Align with key partners to secure lean management review process to support effective decision making and continuous feedback. • Actively promote quality ownership & mindset within related function/organization thru specific engagement initiatives while growing involvement of key partners for role-modeling adherence to quality processes. • Handle functional administration of systems related to QMS (e.g. CAPA, NC, OMSP, LMS) on behalf of the relevant function/organization, providing the needed input according to Corporate QA processes. • Provide required training to end-users to ensure appropriate use of QMS / PS processes and tools. Ensure relevant training content and approach delivery to meet business needs and maintain the skills qualification matrix up-to-date for the functions in scope. • Act as central point of contact for any inspection or audit. Intervene as Subject Matter Specialist and help function/organization in scope get prepared for it. Advance to Corporate QA regarding quality issues or any other critical matters when appropriate and contribute to solve them in close collaboration with function/ organization key partners. • Carry out all of the activities ensuring that Company Compliance Policies, standards, and laws relating to these activities are fully respected, integrated and understood by partners, and implement adequate processes to ensure the security of information of a confidential nature. Who We're Looking For: • Bachelor Degree or Master degree in Engineering/ Life Sciences/ Biology/ Chemistry or equivalent • 5 to 10 years of scientific / technical work experience, preferably in the area of life sciences, engineering and project management. Previous quality experience is preferred • Good command of English is a must • Knowledge of specific functional area (including relevant regulatory standards), some knowledge of regulatory environment. Knowledge of tobacco and reduced risk products, including the regulatory environment surrounding these, would be beneficial. Substantial experience in Quality Assurance in pharmaceutical industries or medical device industries and GxP controlled environment Profound knowledge in FDA and EU GxP regulations relevant for audit/inspections, qualification/validation, compliance systems • Excellent communication, project management and decision making skills Proficient in providing solutions for complex challenges 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. #LIJobs