Details

Contract

Full-Time

Location

Neuchatel, Switzerland

Department

Life Sciences

Openings

1

Job ID

46253834

Sr. Manager Life Sciences Program Quality Management – Neuchatel, Switzerland 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 smoke-free products with the power to improve the lives of a billion smokers worldwide. We’re also exploring new categories, looking beyond nicotine to develop a new portfolio of innovative products. 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 change the lives of millions. Your ‘day to day’ As Sr. Manager Life Sciences Program Quality Management, you will lead the design, development and implementation of a Quality Management System for Drug-Device combination products. You will also provide Quality Management oversight / expertise in project teams ensuring proper documentation and records, risk management plans and effective mitigation actions. More specifically, you'll • Ensure internalization of applicable combination product requirements within the QMS through effective project management and coordination • Drive & govern effective QMS deployment by monitoring execution of deployment, organizing/leading crystallization of processes, aligning on definition, process and responsibilities depending on the business mode, initiating continuous improvement actions on a global level • Guarantee sustainability by regularly performing checks on completeness, adherence to taxonomy and consistency. Implement deployment strategy for major changes/compliance needs • Identify, supervise, and track risks/mitigation actions associated with combination product projects • Ensure project achievements have adequate/applicable support documentation, appropriate level of control according to the project maturity, and the generation of compliant records needed to support product submission, inspection or certification • Guide, train and advise functional quality representatives in the combination product area of quality standards. Who we’re looking for • Bachelor’s Degree in Life Sciences or Engineering, specialization in Quality Management a plus • Substantial experience with combination products quality systems/standards and their implementation within an organization in the pharmaceutical industry. Sound expertise in a GxP environment is a plus • Demonstrated knowledge & experience in Medical Devices is crucial (i.e. ISO 13485, ISO 14971, EU MDR) as well as project and risk management skills • Good knowledge in IT systems, infrastructure environment and tools • Highly collaborative, integrator, strong communicator/influencer with business savy, creativity/fact based analytical skills, technical writing skills, as well as ability to communicate technical knowledge in a clear/understandable manner • Sound analytical/problem solving skills, and ability to work in a multifaceted organization/fast-paced environment • Fluent written and spoken English. What we offer Our success depends on the people who come to work 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 improve the lives of a billion smokers. #LIJobs

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