Clinical Finished Product Quality Lead at Alexion in New Haven, Connecticut

Job Description:

Introduction to role



The Technical Lead 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 manage clinical product disposition, storage, and logistics. This role connects with various teams to ensure governance and metrics for clinical manufacturing quality. You will represent Quality on execution teams, ensuring the supply of safe, compliant, and effective finished products throughout the clinical program lifecycle at Alexion.



Accountabilities

• Lead quality for end-to-end clinical product release, ensuring timely delivery of safe and compliant products for clinical trials.


• Provide technical expertise and governance for IMP release, including GMP batch release, approval of change controls, deviations, clinical labels, and Quality Agreements.


• Collaborate with the PDCS team to meet commitments for clinical finished products.


• Lead problem-solving activities for complex and time-sensitive issues.


• Identify risks, issues, and inefficiencies, leading improvement and remediation efforts.


• Coordinate risk management, change control implementation, deviation/investigation review, CAPA, and batch release.


• Contribute to functional strategy development using industry best practices.


• Mentor and develop team members through matrix management!


• Lead 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 the Director of Quality Operations.

Essential Skills/Experience

• Bachelor's degree in science, pharmacy, engineering or equivalent required


• 10 years GMP experience in the Biopharmaceutical manufacturing industry


• Direct prior experience in releasing clinical finished product, quality systems, and management


• Required proficiencies 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 release of Combination products and cell/gene therapy products is preferred


• Advanced degree a plus. Master's degree 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 are driven by our commitment to serve patients with rare diseases. Our work is led by their experiences and needs, allowing us to tackle the toughest challenges. With a rapidly expanding portfolio and an entrepreneurial spirit, we offer an energizing culture where innovation thrives. Our tailored development programs foster deep understanding of patient journeys, aligning your growth with our mission. Join us to make a meaningful impact in a supportive community dedicated to changing lives.


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



Date Posted

31-Jan-2025



Closing Date

29-Apr-2025Alexion 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. Apply Now