Position Title:  Head Medical Studies Quality

Head of Medical Studies Quality – 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 Head of Medical Studies Quality, you will be responsible for ensuring the highest standards of quality and compliance in the design, execution, and reporting of human studies PMI performs/commissions. This role involves strategic oversight, operational excellence, and leadership in maintaining compliance and quality assurance throughout the Human studies (including Clinical) lifecycle.

More specifically, you'll

• Develop and implement a comprehensive quality strategy for medical (clinical (Interventional and non-interventional) and real world evidence (RWE)) studies and post-market safety surveillance activities, ensuring alignment with regulatory requirements, external standards (e.g. GCP, GEP, GVP) and company objectives. Serve as the primary advisor to senior leadership on associated quality matters, contributing to the broader organizational strategy.
• Lead the team accountable for quality assurance oversight of all medical studies and post-market safety surveillance activities at PMI, ensuring study protocols and reports are in adherence to all applicable standards and regulations, as well as the integrity and accuracy of the resulting data. Lead preparations for regulatory inspections ensuring readiness and compliance.
• Provide strategic direction and guidance to the clinical quality team, fostering a culture of quality and compliance. Provide training and support to staff on quality assurance practices and requirements.
• Oversee audits of study sites, contract laboratories, and other external contract research organizations to ensure adherence to protocols and procedures.
• Provide quality oversight in partnership with Regulatory and Medical teams during preparation of regulatory dossiers and other filings.
• Build and maintain strong relationships internally (Chief Medical Officer and direct repots) and externally, including regulatory agencies, clinical research organizations (CROs), and study sites. Serve as the quality liaison with regulatory agencies and sponsors, ensuring timely and accurate communication.
• Establish and carry out risk-based quality assurance audit plans for medical studies and Life Sciences suppliers and partners, ensuring readiness for regulatory inspections and audits. Partner with Global Head Quality Compliance to lead Life Sciences initiatives to mitigate quality risks, driving a culture of proactive risk management. Provide critical input to Risk Management Plans, influencing decision-making at the highest levels.
• Carry out all of the team's activities ensuring that PMI Compliance Policies, standards, and laws relating to these activities are fully respected, integrated and understood, and implement adequate processes to ensure information is kept confidential when needed.

Who we’re looking fo

• Master’s Degree in Life Sciences, Quality Management, Clinical Research), advanced Degree (e.g., PhD or MD) preferred, or equivalent experience and knowledge to fulfill the scientific competencies for this position.

• Extensive experience in clinical quality management within the pharmaceutical / medical device industry.
• Sound expertise in leading global clinical quality initiatives and managing cross-functional teams.
• In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, ISO 14155) and standards (GCP, GEP, GVP)
• Team management experience.
• Demonstrated expertise in quality documentation & reporting, supplier quality management, quality & compliance management, clinical trial management
• Strong influencing & relationship management skills, innovation & entrepreneurship, problem solving & critical thinking.
• Sound experience in analytics, process excellence, category & portfolio knowledge
• Fluency in both written and spoken English is a must.

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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