Company Overview:

Opella, a consumer healthcare business unit of Sanofi, focuses on Over-The-Counter (OTC) products and Vitamins, Minerals, and Supplements (VMS). Opella is the third-largest global player in this market and is committed to empowering individuals to take charge of their health. Their product portfolio includes over 100 brands, such as Allegra, Dulcolax, and Buscopan, which are trusted by over half a billion consumers worldwide. Opella strives to lead the industry with science-based, consumer-driven self-care products and has earned B Corp certification for their commitment to sustainability.

Mission

The Opella Global Quality Program Owner for Quality Events, Investigations and CAPA defines the requirements of the processes for the  QMS to:

• Ensure adherence of  sites, External Manufacturing Entities, Global GxP Functions and local affiliates worldwide to current legal quality / GMP authority requirements and norms. Assure implementation of emerging regulatory requirements into global processes in alignment with the involved functions (Quality, including Country Quality, Science Hub GxP functions), as appropriate Develop tools (Business System Owner role), processes (Business Process Owner role) and trainings for the assigned Quality systems.

• Execute the corporate business strategy in the area of responsibility.

• Leads transversal projects in the area of responsibility.

• Provide leadership and active support to operative units for quality and compliance related topics and projects, including IT Systems roll out.

Potential Specific Domains

The role requires specific experience and expertise in the field of:

• Knowledge / experience / expertise in the field of:

• • Events (Complaints, Deviations, Laboratory Investigation, OOS, OOT) as source for Investigation

  • Risk analysis as source of investigations

  • Investigation techniques

  • CAPA system

• Applicable regulation relevant for Opella (EU GMP, FDA cGMP, Nutraceuticals, Medical Devices)

• Computerized Systems Compliance (in GxP area)

• Cross functional / transversal management

• Project management

Key Contributions & Activities

Definition of processes:

• Authors the Opella Global Quality Documents for the assigned QMS in collaboration with the impacted functions

• Provide the trainings

• Drives continuous improvement

• Integrates Risk Management principles into Quality systems

• Implements harmonized processes in the QMS solution.

• • Authors user requirements

  • Ensure system’s compliance along life cycle

• Establishes adequate KPIs for data analysis, trending and reporting.

Tools:

• Develops tools for supervising and optimising the overall efficiency of transversal processes in his / her area of responsibility including interfaces

Transversal activities

• Develop and maintains a network with sites, external manufacturing, affiliates, global GxP functions (function involved in the assigned systems) with best practice sharing and cross fertilization

• Develops the adequate quality documents/training materials relative to processes ways of working and tools to support

Scope of Responsibility

Management Responsibilities: No Solid line management.

The role holder is required to work autonomously and to make decisions in line with the Global Quality Policy, Standards and Processes. The role holder has strong compliance mindset, is results-driven, demonstrates can-do-attitude.

Why Join Opella (Sanofi CHC):

• International Work Environment: Work with a diverse, globally distributed team where you can develop your skills and contribute to innovations that impact healthcare.

• Flexible Work Options: Sanofi CHC offers a flexible working model with the option to work up to 60% of your time from home.

• Career Development: Sanofi CHC is committed to fostering both professional and personal development. They provide structured onboarding, continuous training, and mentorship from senior leaders.

• Competitive Compensation and Benefits: Attractive salary package with market-oriented salary, cafeteria benefits, life and accident insurance, and yearly medical check-ups.

• Diversity and Inclusion: Sanofi CHC is committed to diversity, ensuring that all employees are respected and empowered to contribute their best work.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!