Global Head of Quality Systems and Excellence

Global Head of Quality Systems and Excellence

Neuilly-sur-seine

About the job

At Opella., we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Opella., we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Our team: The Opella Global Quality Systems Excellence Head is a member of the Global Quality Leadership team within Opella. Global Quality.

The mission of Global Quality Systems Excellence is to establish, maintain and continuously improve the global QMS built on the strategy orientation of the company, the principles of ICH Q10 and other applicable health related regulations to ensure patient/customer safety and service/product quality in the most efficient way.

The Head of Opella. Quality System Excellence is the functional head of all Global Business Process Owners.

In this function they are the Chair of the Quality Management Review, which is the committee in that all quality systems managed by BPOs (in all functions: Quality, Regulatory Affairs, Medical, Pharmacovigilance, Clinical, ITS) are periodically reviewed in their performances.

Main responsibilities:

He/she:

•creates/leads the development of the overall Opella. QMS strategy

•contributes to the deployment of the overall Opella. QMS strategy with ITS and associated behavioral and cultural mindset

•Ensures that the QMS of Opella. is appropriately segmented for non-drug products/ nutraceuticals etc

The Head of Quality Systems and Excellence is responsible for the Quality Culture Transformation.

The incumbent is responsible to define the Opella. Ways of Working across quality and at the interface with other global functions (e.g. Regulatory Affairs, Medical, Clinical, PV, HR, ITS), the global quality processes and related implementation in the global Opella. QMS.

Potential Specific Domains

The following areas are of responsibility and expertise:

•Project Management

•Strategy transcription in executable plans

•Computerized Systems Compliance (in GxP area)

•Organisation, Communication, and negotiation

•GxP related processes (mainly but not limited to QA and QC) and applicable regulation (including data management and data privacy)

•Financials and budgeting

Key Contributions & Activities

Functional head of all Global Business Process Owners is the functional head of all BPOs independently if located in other quality teams or other teams, delegated to sites or in other global functions (e.g. Regulatory, Medical, PV, Clinical).

•Lead the BPOs in the definition of the Global Quality Processes

•Is accountable for the development of the global strategic plan for Quality training system in Opella..

•Is accountable for the development and Maintenance of the process descriptions the Opella Quality Management system

•Is the Chair of the Opella Global Quality Management Review and ensures that appropriate KPIs are monitored, and decisions are taken to improve the efficacy and efficiency of the QMS

•Ensures regular KPI reporting and the preparation of Quality trend reports

•Enhances development and deployment of digital solutions related to Quality processes (e.g. ERP, QMS, Formula 1 project etc.)

•Defines and leads the transformation using AI in QMS.

Drives the implementation of the Opella. QMS:

•Establishes with ITS the global Quality strategy implementation plan

•Establishes with ITS the appropriate governance to review the deployment and performance of the QMS

•Executes / ensures execution of a robust project management for IT core models solutions supporting QMS

Quality Culture Transformation

•Provides leadership with respect to quality culture, quality mindset and quality cGMP compliance performance and continuous improvement engaging all functions and organizational levels in Opella.. Establishes the use of AI within Quality and Opella.

Project Management:

• Leading specific quality topics or initiatives, as agreed with the Opella. Chief Quality Officer, that impact across Quality and/or Manufacturing / Supply Chain operations and/or Innovation.

• Acts as BPO for defined quality processes

Community of Practices:

•Fosters the set-up of “Community of Practices” and collaboration of BPOs at global and local level.

•Leads CoP for Nutraceuticals. Responsible to ensure that global quality documents for Nutraceuticals are in place and up to date.