Global Head, Life Sciences Quality Assurance

Job content

Global Head, Life Sciences 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’

The role of Global Head, Life Sciences Quality Assurance, is part of the Corporate Quality Leadership team. The core focus of the role is leading all QA related activities in support of Life Sciences strategic business objectives to ensure compliance with all applicable GxP and other internal & external Quality Compliance requirements. Key elements enabling success in the role include

Build an overarching strategy on developing, implementing, and governing a compliance strategy for Life Sciences in the most agile and efficient manner

Oversee the quality and regulatory compliance across Life Sciences’ operations according to requirements for GxP, ISO / EC 17025 & Safety Surveillance

Establish, build, and set team’s direction and objectives to support PMI product portfolio development according to applicable GxP, ISO / EC 17025 and / or other international standards

Ensure inspection readiness and interact with relevant national and international Regulatory Authorities to ensure PMI’s compliance with applicable regulations.

More specifically, you’ll

• Develop, maintain, and improve the Life Sciences quality systems for GxP and ISO / EC 17025 for consistency, efficiency, and effectiveness aligned with PMI QMS
• Develop governance model for collaboration with newly acquired external partner organizations
• Adapt an agile and pragmatic approach to the implementation of regulatory requirements for Life Sciences testing and analytical research laboratories
• Be accountable for ensuring that Life Sciences facilities are ready for regulatory inspections and audits of accreditation bodies, including hosting and facilitating internal and third-party audits / inspections
• Lead a team of specialists in GxPs and other appropriate regulations to ensure that processes, facilities, and related activities are adequately assessed while studies are consequently monitored throughout their conduct for compliance with the applicable regulations
• Supervise, track and monitor remediation and corrective actions in response to internal audits and regulatory inspections. Prioritize and resolve quality issues in areas of responsibilities together with teams accordingly
• Oversee the key quality and performance indicators reporting with respect to GLP, GCLP, ARL, analyze and report trends during Quality Management Review (QMR)
• Present identified risks for the organization to the executive leadership team
• Promote Quality Compliance within Life Sciences to foster and increase quality awareness, and strengthen quality mindset within the organization, through direct interaction and collaboration with the business
• Set the team’s direction and objectives to ensure and contribute to the adherence of PMI RRPs and product portfolio according to applicable requirements and regulations
• Accountable for setting annual budget and managing resources to meet annual budget
• Responsible for implementing lean concepts to continuously improve cycle times within the area
• Work closely with manufacturing management in the areas of cGMP compliance and quality systems. Provide direction in the event of manufacturing incidents that may potentially affect quality or compliance.
  

Who we’re looking for

• Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, Business Administration, Economics, Engineering or related degree required; an advanced degree is preferred
• Extensive experience in a regulated healthcare / device manufacturing environment. Thorough and technical decision-making skills are required and in constant use in this position. Experience in department leadership (organizational, budgeting, strategy) required
• Well-versed in all regulatory requirements, inclusive of cGMP / GLP, ISO, and FDA requirements
• Good knowledge of statistics, databases, and quality principles
• Ability to plan, schedule, organize, prioritize and coordinate project activities, make routine decisions with limited guidance from supervisor, recognize and react to the significance of data and results
• Demonstrated ability to effectively supervise a substantial number of people indirectly / cross-functionally within a project-based, matrix organization, as well as to build relationships and work collaboratively with a variety of individuals within the department, company, external vendors, and customers alike, in fast-paced, team-oriented, and self-directed entrepreneurial environment
• Self-motivated and of high integrity. Ability to use technical knowledge to solve problems, lead teams to achieve results
• Demonstrated high ethical and professional standards. Proficiency in lean / 5S / six sigma methodologies. Advanced user level of MS Office applications. Proficiency in English (oral & written).
  

Leading Change

• Communicate new direction or changes with clear rationale and appeal. Advocate for new direction, take it onboard personally, even countering conventional practice. Champion the quality function by speaking at all available opportunities about future direction. Adjust communication style to changing situations and respond to audience concerns (including culture, background, or style).
  

Collaborating and Influencing

• Negotiate with a genuine give-and-take approach, where both act as true peers and decisions are shared. Spend time connecting to shape a collective consensus. See opportunities to build relationships that will help others achieve their objectives and contact those or new people.
  

Other Personal Characteristics

• Commercial and business-focused with a straightforward manner; be clear-thinking and able to argue a case persuasively and communicate thoughts succinctly. Numerate, highly analytical, and able to synthesize complex data and explain it clearly and logically. Depth of vision to lead the function across cultural boundaries, with the ability to network and communicate across the organization; ability to think strategically and operationally, making things happen, working with and through multiple teams. Must have total integrity and be apolitical, but also have the skill to cope with organizational complexity, ambiguity, and uncertainty.
  

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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