Manager Human Research and Product Safety Quality

vor 1 Woche

Basel, Basel-Stadt, Schweiz Philip Morris International Vollzeit
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.


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

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 riskbased 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 smokefree future.
LI-Hybrid

  • Global Product Safety Scientist

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Company Description: Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere._The...

  • Global Product Safety Science Lead

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Role & FunctionThe Global Product Safety Science Lead is a key role within Global Pharmacovigilance (PV) and Patient Safety. You will be leading the safety surveillance activities for assigned marketed Sobi products and for products under development. As part of our PV team, you will be working collaboratively with other PV functions to ensure that safety...

  • Product Quality Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    About the role:As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products.The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External inspections...

  • Global Product Safety Science Lead

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Hobson Prior Vollzeit

    Salary:CHF CHF190000 per annumJob type:PermanentLocation:Basel, SwitzerlandFunction:PVG & Drug Safety, Global Drug SafetyPosted:28/06/2023Ref:BBBH2292- Hi I'mNyvine, I manage this roleHobson Prior are seeking for a Global Product Safety Science Lead to join a brilliant biopharmaceutical organisation on a permanent basis. Our client is focused on changing the...

  • Manufacturing and Quality Control Manager Gmp

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Universität Basel Vollzeit

    The Department of Biomedicine (DBM) combines the biomedical translational research of the Medical Faculty of the University of Basel and the University Hospital of Basel (USB). Over 900 employees in over 70 research groups at 6 locations in Basel investigate the molecular basis of diseases with the aim of developing new, innovative treatment approaches on...

  • Senior Quality Engineer

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz General Dynamics Vollzeit

    Responsibilities for this Position Location: Basel, CHFlexible Work Arrangement: HybridCareer Level: ProfessionalRequisition Id: 2402Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter,...

  • Senior Quality Engineer

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz General Dynamics Vollzeit

    Responsibilities for this Position Location: Basel, CHFlexible Work Arrangement: HybridCareer Level: ProfessionalRequisition Id: 2402Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter,...

  • Senior Quality Engineer

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz General Dynamics Vollzeit

    Responsibilities for this Position Location: Basel, CHFlexible Work Arrangement: HybridCareer Level: ProfessionalRequisition Id: 2402Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter,...

  • Global Safety Scientist

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Role and FunctionAt Sobi, we...

  • Drug Safety Case Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

    About Idorsia Pharmaceuticals LtdIdorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.Headquartered in Switzerland - a European biotech hub - Idorsia is...

  • Drug Safety Physician

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz NES Global Deutschland GmbH NES Fircroft Vollzeit

    We have an exciting opportunity for a Drug Safety Physician (m/w/d) in SwitzerlandTasks You are responsible for safety aspects of marketed products, including reviewing postmarketing AE reports, signal detection, risk management, and risk minimization. Lead the Safety Management Team, ensuring integration and interpretation of safety information. Coordinate...

  • Quality Assurance Manager Qc

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    About the role:An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 670 employees) for a Quality Manager, within the Quality Assurance Department.This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more...

  • Product Quality Lead

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Company Description At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.**The Product Quality Lead provides cross-functional...

  • Director Drug Safety

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Batterman Consulting Basel AG Vollzeit

    Our client, Skyhawkis a cutting-edge biotech company that is developing innovative small molecules to target RNA processing of disease factors, even those that were once deemed impossible to treat. Their main aim is to create treatments for some of the toughest diseases in the world. They have established a sophisticated, in-house platform that speeds up the...

  • Director, Product Quality Lead

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks....

  • Medical Safety Head

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers...

  • Head of Safety

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz uniQure Vollzeit

    Head of SafetyLocation: Basel (Switzerland)- Education level: MDJob category: CMO Management- Target start date: 3/1/2024Work Location: Hybrid- Shift: 1stuniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This...

  • Quality Assurance

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    Switzerland, BaselQuality Assurance Manager (Supply Chain Compliance Manager)Location: Basle/SwitzerlandFixed Term Contract – End Date December 2025Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people...

  • Quality Assurance

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    Switzerland, BaselQuality Assurance Manager (Supply Chain Compliance Manager)Location: Basle/SwitzerlandFixed Term Contract – End Date December 2025Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people...

  • Quality Manager for Medical Device Startup

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Lumendo AG Vollzeit

    Want to have an impact on the life of hundreds of millions of patients? Become the quality manager at LumendoAbout usLumendo, founded in 2018 and ISO 13485 certified, aims to disrupt the endodontic device market in the US and EU. Our mission is to develop the most advanced solution for this very challenging dental procedure with a disruptive cleaning...