Head of Site Quality

Head of Site Quality

Sanofi

Waterford, Ireland

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.