Director

Description:

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

The Director of Quality will have responsibility for Quality Operations at the Alexion College Park facility in support of clinical and commercial cGMP operations. The position is responsible for driving cGMP oversight of packaging operational activities on site including new product introductions, equipment qualification, process validation, filing reviews, inspection readiness, site documentation issuance / archival, and QP release of ongoing clinical and commercial product.

This role will establish, manage and support continuous improvement activities of all quality systems to ensure compliance, achievement of site goals / objectives and Inspection readiness.

This position is empowered to be the Quality Signatory on all cGMP documents across the site. The incumbent will organize departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements. The Director of Quality may lead investigations, resolve potential quality issues, recommend and implement changes as necessary.