Head of Site Quality Waterford - all genders at Sanofi Aventis US LLC

Waterford, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Control, Compliance, Leadership, Coaching, Continuous Improvement, Digital Technology, AI Solutions, Influencing Skills, Manufacturing, Biopharma, Regulatory Affairs, Training, Mentoring, Process Performance, Product Quality

Industry

Pharmaceutical Manufacturing

Description

About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. About the job This role reports directly to the Site Leader. It’s a critical role ensuring that products are manufactured and released in accordance with cGMPs and other applicable regulations by providing expertise, leadership and direction to site operations. Main responsibilities: Manages the site quality system to ensure that the requirements of cGMPs are met. Ensures that all business objectives are addressed through delivering expected targets across Safety/ Quality/ Distribution/ Cost/ People (SQDCP) elements of the business. Provides overall direction for the site quality groups. Sets Quality System and Compliance objectives for the site. Oversees and supports the effective operation of the Quality Assurance, Quality Control, Quality Systems & Compliance, Qualified Persons and Regulatory Affairs areas to support business needs. Provides functional and business leadership to Senior Leadership Team on site Support Global Sanofi Quality projects and initiatives. Manages the testing and release of products to the requirements of the S&OP plan. Provides inputs to decisions on all topics and activities relating to cGMP and compliance. Leads the Quality team by providing appropriate training, mentoring, review and development to ensure retention of talented people and robust succession planning across key positions. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement. Optimises in-process testing and ensures timely product release to customer requirements. To approve or reject, as sees fit starting materials, packaging materials, and intermediate, bulk and finished products To ensure that all necessary testing is carried out and the associated records evaluated. To ensure site has appropriate specifications, sampling instructions, test methods and other Quality Control Procedures To ensure that the required initial and continuing training of Quality department personnel is carried out and adapted according to need. About you Experience and Education: Degree in Science/Engineering/Pharmacy or Equivalent. Ideally MSc or PhD level qualification in Engineering / Science. Qualified Person (QP) status is required. Experience in QA and QC in a production environment is a must. 15 years industrial manufacturing experience, preferably within the biopharma and/or related regulated industry. Minimum of 10 years in Leadership positions with a proven track record of delivery and compliance. Soft and technical skills Effective Coaching skills to develop people and improve performance. Have demonstrated the ability to design and implement a continuous improvement program. Have demonstrated the ability to deploy and leverage digital technology and AI solutions to transform and modernize how teams work. Strong influencing skills on all levels of the organization. Why choose Sanofi? Bring the miracles of science to life alongside a supportive, future-focused team. Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply. Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation. Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive. Pursue Progress. Discover Extraordinary. Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-Onsite #Sanofi #SanofiCareers #PursueProgress #DiscoverExtraordinary #WeAreSanofi 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! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Head of Site Quality is responsible for managing the site quality system to ensure compliance with cGMPs and other regulations. This role involves providing leadership to quality groups and overseeing the effective operation of Quality Assurance, Quality Control, and Regulatory Affairs.