Head of Market Quality US

UCB • Atlanta, GA

117d

About The Position

This key leadership role involves overseeing Quality operations for our commercial affiliate in the United States, ensuring strong guidance and support. The primary objectives of this role are to seamlessly integrate quality practices at commercial affiliate, ensuring compliance with local and international regulatory requirements across UCB, and providing insight and guidance to the various UCB stakeholders on the US requirements related to quality operations at commercial affiliate. This position also entails responsibility for staff and talent management, including performance management and professional development.

Requirements

• Master's Degree in Scientific and/or Pharmaceutical field and/or Engineering.
• 10+ years leadership experience in the Biopharmaceutical industry within regulated areas (e.g., Manufacturing, Distribution) and/or Quality Assurance expertise.
• In depth knowledge and understanding of the complexity of the BioPharma business and GXP principles.
• Experience in the interpretation and practical application of applicable regulations.

Responsibilities

• Articulate the goals and expectations for your team to secure, establish, optimize and elevate Affiliate Quality operations.
• Ensure the right talents are in place and appropriate resources allocated to achieve quality compliance in-line with UCB's vision and values.
• Oversee the local Quality organization to deliver best in class service and ensure implementation, maintenance and continuous improvement of the local Quality System.
• Drive compliance of all relevant cGxP with local/International regulatory requirements and UCB global standard operating procedures.
• Ensure quality governance and quality planning in the Territories through the establishment and implementation of appropriate Key Quality Indicators.
• Conduct Quality Risk Management Assessments and execute periodic Management Review of Quality Systems.
• Ensure Affiliate readiness for all GxP regulatory inspections.
• Serve as the primary Regional Affiliate Quality contact and collaborate with local operations and management.
• Keep current on all pertinent regulatory publications, international regulations, guidelines and requirements.
• Identify shortcomings and initiate working groups to implement changes following the gap analyses.
• Connect internal and external stakeholders with Local Quality organizations to facilitate a holistic approach of GxP regulatory compliance.
• Ensure quality oversight and direction to local vendors and partners.

What This Job Offers

• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree