Qualification & Validation Lead

About the job

AtOpella., we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, 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.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

Our Team:

Brief introduction of the department, team, purpose, and missions (including KPIs). Highlight what is unique to your team.

Main responsibilities:

The Global Quality Qualification and Validation Lead is member of the CHC Global Quality System team and is responsible to maintain and improve the Quality Management System (QMS) across the worldwide organisation.

In particular the incumbent is responsible as a Business process Owner to define the requirements for the Opella Quality Management System to:

Ensure adherence of Opella. internal sites, Global GxP Functions, External Manufacturing Entities, and affiliates to current legal quality / GMP authority requirements and norms.

Assure implementation of emerging regulatory requirements into global core processes and requirements in alignment with the involved CHC functions (engineering, digital, quality at local and global level)

Develop tools and applications (Business System Owner role), processes (Business Process Owner role) and trainings for the assigned Quality system, as appropriate

Drive continuous improvement

Execute the corporate business strategy in the area of responsibility

With this respect the incumbent is responsible for streamlining operational processes, mutualizing execution activities, and ensuring cross-regions key learnings and good practices sharing and related communication to contribute to agility in execution.

The incumbent ensures that appropriate tools are developed with the responsible digital function and adopted by the local organisation.

• Transversal activities:
  • create a network of experts for the area of responsibility in all entities
  • Develops & maintains networking within the different entities with best practices sharing and cross-fertilization
  • Support organisational change management activities (e.g. preparation and performance of training sessions, share best practices) through adequate communication
  • Perform data analysis and trends of Quality processes
  • Support and assist of department projects and programs, including quality culture activities

About you

• With a track record of at least 5 years in Quality Management System within dynamic environments, particularly in the pharmaceutical industry or a comparable field, you bring a wealth of proven experience.
• Notably, your experience extends to successfully managing and coaching teams. 

• You stand out as a champion of change management, showcasing remarkable adaptability to evolving regulatory requirements. Your ability to seamlessly implement changes and drive continuous improvement has become a hallmark of your professional approach.

• As a proactive problem solver and decision-maker, you excel in addressing challenges, offering practical solutions within the realms of the training management process.

• Your forte lies in communication, as you are an expert with robust interpersonal and communication skills. This proficiency enables you to facilitate effective interactions with diverse teams and stakeholders at various organizational levels.

• Mandatory proficiency in English further complements your comprehensive skill set.

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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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