Job title: Qualification & Validation Expert, Report Issuance
About the job
Global Manufacturing & Supply (M&S) Services is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S services. The team members of Global M&S Services (Report Issuance) will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established Global Quality processes from the hubs. The Qualification & Validation Report Issuance team is responsible for authoring facilities, utilities, and equipment (FUE) qualification documents, including initial qualification protocols, reports, and requalification reports, quality review reports. This includes comprehensive activities such as data collection, analysis, drafting, document control, review, approval, sign-off, and preparation for inspections and audits.
Main responsibilities:
- Perform comprehensive content and technical writing and reviews to ensure accuracy, completeness, and compliance against approved Templates, protocols and guidelines for facilities, utilities, and equipment (FUE) qualification documents, including initial qualification protocols, reports, and requalification reports, quality review reports.
- Review for accuracy and completeness of all data in protocols & reports. Align documentation standards with global Quality requirements and maintain consistency across all qualification and validation team deliverables. Verify accuracy of all data, references, and citations included in protocols, reports to ensure regulatory compliance.
- Ensure equipment qualification activities comply with Quality regulations and pharmaceutical practices. Summarize key findings and provide clear, protocol-aligned interpretation of results. Perform report signing in Veeva CMS or Kneat.
- Perform comprehensive content and technical writing and reviews to ensure accuracy, completeness, and compliance against approved Templates, protocols and guidelines for facilities, utilities, and equipment (FUE) qualification documents, including initial qualification protocols, reports, and requalification reports, quality review reports.
- Review for accuracy and completeness of all data in protocols & reports. Align documentation standards with global Quality requirements and maintain consistency across all qualification and validation team deliverables. Verify accuracy of all data, references, and citations included in protocols, reports to ensure regulatory compliance. Ensure equipment qualification activities comply with Quality regulations and pharmaceutical practices. Summarize key findings and provide clear, protocol-aligned interpretation of results.
- Translate and adapt protocol, report communications for sites, hubs ensuring clarity and alignment using appropriate Tools. Monitor and track execution of activities against defined timelines to achieve established KPI targets, escalating delays as necessary. Ensure to complete all training in a timely manner. Provide training and guidance to team members on compliance topics and best practices.
- Ensures full compliance with GxP principles, regulatory requirements, and Sanofi Quality standards throughout equipment qualification and validation processes. Manage Quality Management System (QMS) records, address discrepancies, and ensure timely closure of all related documentation. Support internal audits and inspections if any by providing required equipment Qualification and validation documentation.
- Drive continuous improvement initiatives through standardization, simplification, and digitalization of equipment qualification processes. Perform all tasks in compliance with Good Manufacturing Practice (GMP) and Health, Safety, and Environment (HSE) requirements, following established instructions, procedures, and records. Execute additional duties as assigned by the manager or team lead, as needed, beyond the responsibilities outlined above.
About you:
- Experience: >5 years’ professional experience in qualification
- Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments
- Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point
- Education: Bachelor's degree in Engineering, Pharmacy, Chemistry, or a related field. Advanced degrees (e.g., MSc, PhD) preferred
- Languages: Excellent English communication and writing, French or other Languages in addition preferred
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.
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!