Head Of Quality

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of over 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.

About the job

This role reports directly to the Site Leader. 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

• Degree in Science/Engineering/Pharmacy or Equivalent.
• Ideally MSc or PhD level qualification in Engineering / Science.
• Qualified Person (QP) status is required.
• 15 years industry experience, preferably within the biopharma and/or related regulated industry.
• Minimum of +5yrs in Leadership positions with a proven track record of delivery and compliance.
• Effective Coaching skills to develop people and improve performance.
• Have demonstrated the ability to design and implement a continuous improvement program.

It would be advantageous to have (not essential):

• In-depth understanding of the broader business.
• Strong influencer at SLT and Corporate Network level.
• Strong change management understanding at an organisational level.
• Demonstrated program management skills.
• Demonstrated people leadership skills.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. 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 colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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 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.