Qualified Person
* Location: Waterford
About the job
At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need.
For over 20 years, our Waterford team has grown and diversified to serve patients worldwide. Today, nearly 800 employees work at our state-of-the-art biopharmaceutical and medical device campus. Recognized with multiple awards, Sanofi Waterford offers flexible working arrangements and a range of opportunities for career growth. The site features attractive benefits, including an onsite gym and medical center, emphasizing our commitment to health and wellbeing.
The Quality Assurance team comprises QPs, Managers, Technical Leads, Team Leads, and Quality Specialists dedicated to transforming medicine practices and providing life-changing treatments globally. Working in this team means contributing to a state-of-the-art sterile filling facility producing both commercial and clinical products, with a robust pipeline. We are expanding and seeking additional quality professionals.
We are a global healthcare company driven by the purpose of advancing science to improve lives. We offer a nurturing environment for career development, with numerous opportunities to connect, learn, and challenge your limits. Are you ready to begin?
Main responsibilities
The Qualified Person ensures that licensed products are certified and released to market in accordance with EU directives 2001/83/EC, 2004/94/EC, and Annex 16 requirements.
* Manage batch disposition processes to ensure timely product release.
* Maintain compliance of batch disposition with site practices and regulatory standards.
* Support major investigations, ensuring all deviations are resolved before batch release.
* Participate in cross-functional teams as the Quality/Qualified Person representative.
* Provide additional support for quality issues as needed.
* Contribute to internal committees and teams as required.
* Advise departments on quality matters.
* Ensure independence in quality-related decision-making.
* Foster partnerships across the business to promote excellence in quality and compliance.
* Support internal and supplier audits as needed.
* Keep up-to-date with pharmaceutical legislation and industry practices.
About you
Preference for candidates with advanced degrees and at least eight years of cGMP experience, including experience as a Qualified Person listed on the Manufacturer's/Importer’s Authorization (MIA). Relevant experience and education will also be considered.
* Proven leadership skills, with at least 2 years of management responsibility.
* Postgraduate qualification (MSc or equivalent).
* Biologics manufacturing experience highly desirable.
* Experience in sterile manufacturing and clinical trials regulations preferred.
* Excellent training and mentoring skills.
* Strong oral and written communication abilities.
* Competence in problem-solving, risk assessment, and impact analysis.
Why choose us?
* Join a supportive, innovative team bringing science to life.
* Explore opportunities for growth and career development locally and internationally.
* Enjoy a comprehensive rewards package that recognizes your contributions.
* Benefit from extensive health and wellbeing programs, including high-quality healthcare, wellness initiatives, and at least 14 weeks of gender-neutral parental leave.
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