Job title : Qualification & Validation Lead
About Opella
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people' s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
Headquartered in France, Opella is the proud maker of many of the world' s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com .
About the role
The Qualification & Validation Lead — Shall act as a Business Quality Representative (BQR) for various enterprise projects in the Computerized Systems Compliance domain within the GxP area. This role takes responsibility for ensuring adherence to the global validation processes, coherent application of Opella's Validation & Qualification requirements. He/ She shall serve as a Subject Matter Expert (SME) and act as key link between Local Process Owners (LPOs) and Global Quality, providing guidance and active support for IT Systems rollout, maintenance, and qualification activities.
This role also authors various domain related standards, procedures and workflows.
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.
Main Responsibilities
CSV Strategy & Governance
- Develop and implement Computerized System Validation (CSV) strategies aligned with regulatory requirements.
- Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and data integrity principles.
- Maintain and improve CSV frameworks, policies, and procedures.
- Guide the Q & V teams on validation aspects of Digital Applications, to ensure compliance to requirements of data integrity and applicable regulations.
Business Quality Representative:
Act as BQR to Oversee validation of various enterprise applications used in GxP domain such as:
- Laboratory systems (LIMS, CDS)
- Manufacturing systems (MES, SCADA)
- ERP and supporting GxP systems
- Training & Content Management Systems
- Serialization and Regulatory Information systems
Approve validation deliverables and documentation.
Apply risk-based validation approaches (GAMP 5).
Q&V Support:
Partner with:
- Digital teams for system implementation and changes
- Technical system owners Business owners for system requirements
Provide CSV guidance for projects, upgrades, and system changes .
Mentor team members and stakeholders on best practices. Review and update the Global Quality documents pertaining to processes for Q & V in alignment with the applicable emerging regulatory requirements.
Drive simplification, standardization, and continuous improvement in validation processes.
Be the SME for Q & V and support QA teams to prepare for regulatory inspections, answer any queries raised by the Inspectors and work out CAPA to close any gaps identified by the Inspectors.
Required Qualifications
Education
Bachelor's or master’s in engineering, Computer Science, Pharmacy, Life Sciences or related field,
Experience
Minimum 10 years of progressive experience in handling CSV in Pharma/ Nutraceutical domain. Must have experience in handling enterprise level projects for deployment of GxP applications.
Q&V
Advanced knowledge of Computerized System Validation (CSV), GAMP, Computerized System Assurance (CSA), Data Integrity (ALCOA+), Quality Management Systems (QMS), GxP regulations and compliance (USFDA, MHRA, TGA etc.)
Agile & Data
Familiarity with Scrum/Agile, Jira, and Confluence; comfort with KPI tracking and reporting tools.
Skills & Profile
- Proactive and autonomous — able to manage multiple priorities in a global, matrixed organization.
- Strong decision-making and problem-solving
- Effective communication and influence
- Ability to work cross-functionally
- Results-driven mindset with attention to detail & genuine curiosity for Q&V topics, Operations, Quality systems, Science.
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
