Manager Human Research and Product Safety Quality Assurance

Job content

Manager Human Research and Product Safety Quality Assurance – Neuchâtel, 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 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 day-to-day

As a Manager Human Research and Product Safety Quality Assurance, you will be accountable for the GCP/GEP compliance across the PMI Organization for all studies involving Human subjects, including compliance oversight of all GCP/GEP related activities pertaining to studies involving Human subjects, as well as for the GVP compliance across the PMI Organization for all research and post market related safety surveillance processes, and be responsible to supervise the global PMI Clinical Quality Assurance group in the Corporate Quality organization, leading and coaching the team in providing them with all necessary resources to implement the governance for GCP/GEP and GVP compliance, as well as to develop and to lead strategic Clinical QA plans and schedules to ensure compliance of the Clinical and Regulatory Insights Organizations with external and internal requirements (eg GCP, GEP, MRTPa) for reduced risk products (RRPs).

More specifically, you will

• Lead and set team direction to contribute to adherence of PMI products to predefined rules and regulations. Ensure the full alignment with functional strategy and its deployment within the team led. Set team objectives and collaborate across departments to ensure targets are achieved. Consistently build GxP QA capability, by providing continuous coaching, mentoring and advice to all direct and indirect reports.
• Supervise the Quality Assurance Unit for the GxP functions (GVP, GCP, GEP) in order to ensure that all studies in Humans are monitored throughout their conduct for compliance with the applicable GxP regulations, and that the site/facility is audited to assess compliance with GxP regulations, through a risk-based approach to audit planning.
• Be responsible to provide independent objective advice and interpretation of GxP regulations, through the compliance oversight and regular monitoring of GxP standards. Be accountable to present on GxP regulations, as a valuable way to help others achieve compliance. (e.g. fraud and scientific misconduct).
• Be responsible to ensure the compliance of product safety and surveillance processes both within the human research and post market area.
• Be accountable to oversee the metrics reporting of the function at local management review level, whilst working with the quality management review team to raise the necessary GxP metrics to the functional level review.
• Be responsible to promote QA within the organization, to foster the notion of ownership of the quality and to strengthen Quality culture in the organization, through direct interact with the GxP functions.
• Support the inspection readiness of the PMI organizations involved in Human research and safety surveillance, ensure the inspection readiness at all times.
  

Who we are looking for

• PhD (preferred) or Master in Life Sciences, Biology, Chemistry.
• Substantial experience preferably in GxP (GLP, GCP, GEP), leading people or teamwork. Sound experience in GCP QA environment and GVP is required.
• Experience in a GLP environment is an asset.
• Sound expertise in participation, management, and hosting of external regulatory body inspections.
• Demonstrated lead auditor experience, as well as in maintenance of quality management systems and continuous improvement processes.
• Strong knowledge of current regulatory guidance mainly US and EU
• Ability to foster a collaborative culture
• Strong communication skills; proficient in English, both written and spoken.
  

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 a smoke-free future.