- Location Waterford
- Job type: Permanent
For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 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
- Ensures that all business objectives are addressed through delivering expected targets across Safety/ Quality/ Distribution/ Cost/ People (SQDCP) elements of the business
- Oversees and supports the effective operation of QC to support business needs
- Leads the QC teams by providing appropriate training, mentoring, review, and development to ensure hiring and retention of talented people and robust succession planning across key positions
- Working as a senior member of the Quality Leadership team to embed the overall Quality Vision and ensuring the delivery of the Site Strategy which is driven by a fast-changing environment
- Leads and directs QC standardization and transformation
- Develops the organizational model to achieve excellence in execution to enable performance acceleration and support growth
- Builds an integrated and agile QC system, builds a fully integrated Equipment Management programme, and develops agility
- Enhance our QC operations and activities by leveraging new technologies, increasing efficiencies, and strengthening processes and product robustness
Compliance Related Tasks
- Assure compliance of equipment, methods and testing with GMP regulations and regulatory expectations
- Fully completes departmental objectives and complies with budget targets
- Meets safety and environmental performance
- Ensures implementation and maintenance of site quality system
- 15 plus years industry experience, ideally in a Quality or Operations role, with at least 5 plus years leadership experience.
- Sterile manufacturing experience
- Extensive Product Release experience required
- Hands-on experience of cGMP management within a Pharma or Biopharma company is essential
- Experience will include exposure to regulatory authorities
Need to Know
- Degree, ideally in Science or Pharmacy, is a minimum requirement
- A higher degree in Science, Pharmacy, Engineering or equivalent is desirable
Skills & Knowledge
- Knowledge of sterile manufacturing is necessary
- Knowledge of Regulatory Affairs and Validation is necessary
- Proven ability to direct cost-effective quality programmes in a highly regulated environment
- Achievement of world class levels of performance through continuous process improvement
- Ability to actively participate and contribute to the senior site management team
- Strong strategic / financial / commercial awareness
- Strong leader providing clear direction to reports and effective team management
- Independent, open-minded thinker and a good active listener
- Energetic in the pursuit of improved processes and ultimately of improved performance
- Analytical and thorough in the completion of their work
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.
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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.