Quality Manager, Finished Product Quality Operations

Responsibilities

• Oversee operational quality activities for the packaging and disposition of commercial and clinical finished products at the College Park facility.
• Manage a team of Quality professionals to ensure timely and efficient execution of responsibilities.
• Ensure all manufacturing and release activities comply with Alexion QMS and relevant cGMP regulatory requirements.
• Partner with internal stakeholders including Packaging Operations, QC, Regulatory, and Engineering, as well as external QA and CMO sites.
• Drive continuous improvement initiatives and address remediation from inspections or quality improvement plans.
• Provide quality oversight for deviations, investigations, and change requests to ensure robust root cause analysis and timely closure.
• Support the preparation and management of Health Authority inspections and act as a key representative for regulatory bodies.
• Manage the issuance, control, and archival of batch records and manufacturing documentation.

Requirements

• Minimum of 8 years of relevant experience within the biopharma industry.
• Minimum of 3 years in a supervisory or managerial role.
• Direct experience of GMP management within a biopharma company, including exposure to FDA, HPRA/EMA, or similar authorities.
• Proven experience in regulatory inspection management.
• Strong technical writing skills.
• Demonstrated ability to lead, mentor, and develop personnel within a Quality Management System.
• Excellent interpersonal and communication skills.

Preferred Qualifications

• BS in science with 8 to 10 years of experience in a cGMP Quality environment.

About the Company

Alexion, an AstraZeneca company, is dedicated to developing life-changing therapies for people with rare diseases. We strive to build an inclusive and equitable environment where all employees feel they belong.