Position Title:  Manager Clinical Quality Assurance

Manager Clinical Quality Assurance - 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 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 Clinical Quality Assurance, you will be accountable for the Good Clinical Practices (GCP) and Quality Management System (QMS) compliance across the Life Sciences Organization for Clinical Studies and Clinical Operations. You will also be accountable for  Product Safety Surveillance (PSS) and where applicable the oversight of GCP-related activities pertaining to Observational Studies, and responsible to ensure that the Clinical Operations and PSS QMS are developed and maintained in compliance to GCP and other applicable national and international regulations and standards.

You will be responsible to develop and lead strategic risk-based Quality Assurance  programs to ensure compliance of Clinical Operations activities with internal and external requirements (e.g. PMI QMS, GCP) for Smoke Free Products (SFPs), and responsible to implement them by conducting internal audits as well as defining the strategy and leading the process for outsourced audits (e.g., external audit supplier selection, qualification, and contracting).

You will also support Medical Sciences (e.g., Clinical Operations, Safety Surveillance) in quality system documents management acting as document controller, Nonconformities (NC) investigations and Corrective/Preventive Action (CAPA) management (acting as NC/CAPA coordinator), and inspection readiness activities.

More specifically, you'll

• Lead the Quality Assurance activities such as planning, scheduling, performing, reporting and following up for Clinical Operations on routine and non-routine process, systems and study-based audits to ensure internal systems and processes are in accordance with relevant PMI and national/international requirements for GCP.
• Be responsible to provide timely and adequate guidance to Medical Sciences to ensure that Clinical and Safety Surveillance Operations are aligned with GCP and other applicable regulations and standards and in conformance with national/international regulations throughout the study lifecycle.
• Ensure the development and harmonization of Life Sciences Quality Assurance Standard Operating Procedures (SOPs) and other quality documents to align with the PMI Quality Organization. Perform Quality Assurance review of SOPs and other quality documents to ensure compliance with GCP, other applicable regulations and the PMI QMS/Policies for Smoke Free Products (SFP).
• Provide support in the implementation of data integrity requirements and validation of computerized systems supporting GCP studies.
• Responsible to promote Quality Assurance within the organization, to foster the notion of ownership of the quality and to strengthen Quality culture in the organization, through direct interaction with the Life Sciences functions.
• Act as NC/CAPA coordinator for Clinical Operations and Safety Surveillance in reviewing, approving and following up on Nonconformities and Corrective and Preventive Actions (CAPA), including those from audits and inspections.
• Support inspection preparedness and readiness activities in collaboration with Quality Compliance (e.g., Always Inspection Readiness Team) and with Medical Sciences management to ensure that the Clinical Research and Safety Surveillance organizations are ready at all times for regulatory inspections.

Who we’re looking for

• Master’s Degree (PhD is preferred) in Life Sciences, Biology, Chemistry, or equivalent experience.
• Minimum 6 years’ experience in Clinical Quality Assurance and Risk Management, in Pharmaceutical industry / Life Sciences area (e.g., Good Clinical Practices - GCP, Good Epidemiological Practices - GEP, Good Pharmacovigilance Practices - GVP), including minimum 2 years’ experience in Quality Assurance in the context of a Life Sciences, ISO 9001 or equivalent Quality Management System. Leading people or teamwork is an advantage.
• Demonstrated Lead Auditor experience (i.e. at least 5 site audits, third parties’ audits and internal audits conducted).
• Sound expertise in maintaining Quality Management Systems and developing performance monitoring tools. Strong knowledge of ICH Good Clinical Practices.
• Demonstrated ability to foster a collaborative culture with all teams and communicate confidently at all levels. Practical problem-solving and strong organizational and prioritization capabilities. Ability to function both independently and within a team, as well as to prioritize workload.
• Fluent 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.

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