Overview
Clinical Finished Product Quality Lead Jobs in New Haven, Connecticut, USA at Alexion Pharmaceuticals
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.
Minimum Requirements
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.
Prior experience with release of Combination products and cell/gene therapy products is preferred.
Advanced degree a plus. Master’s degree preferred.
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-2025
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Title: Clinical Finished Product Quality Lead
Company: Alexion Pharmaceuticals
Location: New Haven, Connecticut, USA
Category: Healthcare (Data Scientist, Medical Science), Quality Assurance – QA/QC
