Associate Director, Clinical Finished Product Quality at Alexion in New Haven, Connecticut

Job Description:

Introduction to role


The Associate Director for Clinical Finished Product Quality will provide technical support to the Quality Operations team, ensuring timely and compliant oversight of clinical finished products. As a quality partner to the Global Product Development Clinical Supply (PDCS), you will oversee clinical product disposition, storage, and logistics. This role connects with various teams, including Clinical Product Quality Leads (PQL), Drug Substance & Drug Product Quality, and QPs, to ensure governance and metrics for clinical manufacturing quality. You will represent Quality on execution teams to ensure the supply of safe, compliant, and effective finished products throughout the clinical program lifecycle at Alexion.


What you'll do:
• Quality lead for end-to-end Clinical product release enabling on-time delivery of safe and compliant product for clinical trials, liaising with Quality operations partners (DS/DP) and Clinical PQL.
• Provide technical expertise to the team and partners with PDCS to provide governance and oversight for IMP release. Activities include but are not limited to GMP batch release, approval of change controls, deviations, clinical labels, and Quality Agreements.
• Collaborate with the PDCS team to ensure on-time commitments for clinical finished products.
• Lead problem-solving activities for complex and time-sensitive issues. Ability to lead and execute highly complex or specialized projects; adapt precedent and may make significant departures from traditional approaches to develop solutions.
• Proactively identify risks, issues, and inefficiencies and lead improvement and remediation efforts.
• Provide quality oversight of risk management, change control implementation, deviation/investigation review, CAPA, and batch release.
• Use expertise or unique knowledge and professional concepts & industry best practices to contribute to the development of functional strategy and achieve objectives in creative and effective ways.
• Coach and provide technical development of team members (matrix management).
• May lead and manage cross-site forums, including Change Control Review Board and Quality Management Review.
• Manage GxP audits and inspections, including readiness activities.
• Act as a delegate for Director, Quality Operations.


Essential Skills/Experience
• Bachelor's degree in science, pharmacy, engineering or equivalent required; advanced degree a plus. Master's degree preferred.
• Ten (10) years in a GMP role in the Biopharmaceutical manufacturing industry.
• Direct prior experience in releasing clinical finished product, quality systems, and management.
• Required competencies include data integrity, computer system validation, quality systems management, Disposition of investigation medicinal products, and in-depth knowledge of GMP, GCP, and GDP regulations.
• Ability to make decisions, solve problems with pragmatic solutions, and manage ambiguity.
• Ability to collaborate, negotiate, influence, and lead in a matrix organization.
• Excellent verbal and written communication skills.


Desirable Skills/Experience
• Prior experience with the release of combination products and cell/gene therapy products is preferred.


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


At AstraZeneca's Alexion division, we push the boundaries of science to deliver transformative medicines for rare diseases. Our commitment to transparency, objectivity, and ethics drives us to innovate continuously. With our global reach and resources, we are uniquely positioned to address unmet medical needs and help people live their best lives.


Ready to make a difference? Apply now to join our team!



Date Posted

21-Mar-2025



Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.