Manager Human Research and Product Safety Quality Assurance
Jobbeschreibung
Neuchâtel, Neuenburg, Schweiz
Philip Morris
03.05.2024
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DetailsLocationNeuchatel, SwitzerlandManager Human Research and
Product Safety Quality Assurance – Neuchâtel, SwitzerlandBe 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-dayAs
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.#LI-HybridApply
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Manager Human Research And Product Safety Quality Assurance
Philip Morris
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