Executive Director, Site Quality Lead

Job Description

At our company's Wilmington Biotech site, we are committed to ‘Using the power of leading-edge science to save and improve lives around the world’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

The Wilmington Biotech site will play a pivotal role in the manufacturing of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds with full manufacturing and testing operations.

This facility will be a significant supplier of antibody drug conjugates and high potent compounds and will also be critical in the future supply of new biotechnology products to its global network.

Reporting to End-to-End Operating Unit Quality Operations, and a member of the Site Leadership Team, the Site Quality Lead plays a key role in the delivery of digitized, compliant Quality systems and processes to support the development, technology transfer, manufacture, testing and disposition, stability and storage of products manufactured at the Wilmington Biotech site.

Direct responsibility for correct execution of all phases of Quality Assurance of the Wilmington Biotech site from facility design through to routine testing and production. Responsible for implementing procedures and programs so that the quality department operates effectively and in a timely and cost-effective manner to assure high quality products from the Wilmington Biotech site. Ensure that objectives are effectively achieved, and are consistent with our company’s requirements to ensure compliance, safety and reliable supply to our customers.

• Identify, recruit and manage the Quality Leadership Team, implementing a strong quality culture and ensuring staff engagement and development in line with the site competency framework.
• Demonstrate Quality leadership to the site providing guidance and interpretation on the regulatory requirements for the phase appropriate manufacture and of the products at Wilmington Biotech
• Lead the Quality team in demonstrating a strong culture of customer support (internal and external) setting up compliant processes that are understood, easy to follow and reduce waste. Developing and maintaining a management philosophy and accountabilities which encourage continuous improvement to reduce risk.
• Member of the Capital Project Leadership Team driving the design, construction, and qualification of the new site and establishment of the critical site into our company's network.
• Drive a high performing and inclusive culture, stimulating personal growth and development.
• Drive the establishment and licensure of a fully digitized facility to support both commercial products as well as clinical supply.
• Build relationships with internal departments, regulators, customers and external organizations to support the development and growth of the business. Encourage collaborative/supportive working within the different departments and across functional interfaces.
• Prepare annual budgets (Profit Plan and Capital) for the Quality department and is responsible for budgetary control, ensuring that any deviations from approved Profit Plan and Capital Plan are agreed in advance with the Vice President, Global Biologics.
• Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
• The core areas of:
• Quality Compliance, such as managing pre-licensure meetings and regulatory inspections, the site auditing program, customer complaints, investigations and CAPAs including fact finding and recall activities as required. Serve as the Primary point of contact for regulatory agency inspectors.
• Quality Assurance including implementation and maintenance of QMS documentation systems, change management, Quality Risk Management, Quality agreements, Batch record review and disposition. Provide Quality oversight of deviation investigations,…