Qualified Person

Qualified Person

About Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland's southeast coast.

Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds, and experiences.

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 employees, patients, and customers.

Main responsibilities:
The Qualified Person is responsible to ensure that licensed product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.

• Manages the batch disposition process to ensure timely release of product
• Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
• Support major investigations, ensuring all product deviations are closed prior to batch release
• Participates in cross functional teams as Quality/Qualified Person representative
• Provide additional QP support to quality related issues, as the need arises
• Participates on internal committees/teams, as required.
• Provides advice and direction to other departments on quality issues.
• Ensure independence of the QP on decisions on quality related matters.
• Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Provide audit support as required for internal auditing program and supplier audits.
• Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice

About you

• Preference given to candidates with advanced degrees; eight or more years of cGMP experience preferred with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA) ; consideration will be given to other relevant experience and education
• Proven leadership skills comparable to 2+ years of management responsibility.
• Post Graduate Qualification required (MSc or equivalent)
• Biologics manufacturing experience highly desirable
• Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable.
• Excellent training/mentoring experience
• Excellent oral and written communication skills
• Competent problem solving, risk assessment and impact analysis abilities

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, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
 

Apply today or contact myself at [email protected] for further information.