Manager, Quality Management Systems & 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., you will work at electronic Product Development Center (ePDC) which is under PMAL. We are seeking a highly capable individual to join our team as the Manager, Quality Management Systems and Compliance. In this role, you will be responsible for driving development, implementation, and maintenance of digital quality tools and practices for PMI electronics device business. Your main duties will include coordinating and facilitating the evaluation, development and upkeep of training matrices in collaboration with multi-functional groups. Additionally, you will establish, communicate and maintain quality metrics to ensure consistent alignment to our internal standards. Working closely with the Global Quality team, you will play an integral role in ensuring compliance with internal standards. As part of your responsibilities, you will coach and manage a team of subject matter experts (SMEs) while effectively handling resources, ensuring multi-functional collaboration with other internal functions and third-party manufacturers. Key Responsibilities: • Lead a team to complete day-to-day management of an Electronic Document Management System (EDMS), Learning Management System (LMS) and Electronic Quality Management System which includes complaints and change control. • Evaluate training assignments, develop training matrices, and ensure the maintenance of training records, while leading all aspects of the timeliness of training completion. • Train end users on document change controls (DCCs), the use of templates, and the Veeva workflow, including reviews and approvals. • Partner with the IT department to leverage the full capabilities of the Quality System, including data visibility, data analytics, automation, and data exchange. • Establish, maintain, and effectively communicate quality metrics, And contribute to drive continuous improvement initiatives across the organization, identifying areas for improvement and implementing standard processes. • Participate in internal audits, taking an active role in assessing compliance and initiating revisions to SOPs. Support and coordinate third-party vendors audits and regulatory inspections (including mock FDA Readiness). Coordinate GxP training to ensure companywide compliance. Who we’re looking for • A candidate with a university degree in Manufacturing/Industrial Engineering or equivalent, along with direct experience in people and/or project management. • Possesses an extensive knowledge (10+ years) of cGxP, Quality Risk Management and QMS, preferably in a highly regulated environment such as medical, pharmaceutical, automotive, or aerospace industries. Familiarity with applicable guidelines and regulations is crucial, and experience with CFR 820 and 1120 is considered a significant advantage. • Capable of actively participating in project planning and prioritization. • Demonstrates the ability to coach and develop team members, improving their capabilities and expertise. • Able to thrive in a fast-paced environment with multiple concurrent priorities across different geographical locations and departments. • Exhibits proactive problem-solving skills, anticipating and mitigating issues. • Possesses strong leadership skills to drive cross-functional teams, as well as internal SME team. • Excellent interpersonal and communication skills, with the ability to report at all levels of the organization. • Proficient in producing high-standard documentation and reports. • Fluency in English is a prerequisite, while Chinese speaking and writing skills are highly desirable. 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