About the Opportunity
This role reports directly to the Site Leader with a dotted line to Director, Quality Site Support GMQO. This critical role located onsite ensures that products are manufactured and released in accordance with cGMPs and other applicable regulations by providing expertise, leadership and direction to site operations.
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.
Key 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.
To excel in this role you will need to have :
Essential requirements :
Degree in Science / Engineering / Pharmacy or Equivalent.
Ideally MSc or PhD level qualification in Engineering / Science;
Qualified Person (QP) status is desirable;
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 strategic / financial / commercial awareness;
Strong influencer at SLT and Corporate Network level;
Strong change management understanding at an organisational level;
Demonstrated program management skills;
Demonstrated people leadership skills.
What Sanofi can offer you :
A role where you are instrumental to creating best practice and as the organisation grows, you can too;
We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us;
A newly refurbished gym is available onsite;
You will be based in our Waterford site which is accessible from M9;
Parking available onsite;
This is a full time role and we support flexible working.
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.
Empower Life Everyday.
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career.
Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world.
Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems.
We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
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.
Sanofi, Empowering Life