Clinical Product Quality Lead

AstraZeneca • New Haven, CT

92d

About The Position

Are you ready to make a significant impact in the world of clinical product quality? As a Clinical Product Quality Lead (CPQL), you'll be at the forefront of ensuring the highest standards of quality from candidate selection through to commercial approval. You'll be the Quality representative on the CMC Team, collaborating with cross-functional stakeholders to support clinical product scale-ups, accelerations, integrations, and partnerships. Your expertise will guide strategies for compliant, on-time release of first-in-human (FIH) products and oversee quality activities throughout early and late-stage clinical programs. Are you up for the challenge?

Requirements

• 8 years+ experience in GMP Quality Assurance in a pharmaceutical manufacturing environment, including 5 years + experience with Phase I, II and III product development.
• BSc. degree in biological / chemical sciences, or a related pharmaceutical science.
• Minimum 5 years’ experience with genomic medicines.
• Experience with review of market applications, INDs, supplements, and similar regulatory documentation.
• Experience working with contract manufacturing and laboratory organisations.
• Understanding of phase appropriate cGMP, pharmaceutical drug product development and manufacturing.
• Knowledge of quality systems, including product release (Annex 16) and quality control.
• Demonstrate learning agility and a growth mindset.
• Ability to make decisions, solve problems, and manage ambiguity.
• Ability to collaborate, negotiate, influence and lead in a matrix organisation.
• Excellent verbal and written communication skills.

Nice To Haves

• Prior experience with combination products.

Responsibilities

• Provide quality oversight for various clinical products across different presentations, from pre-clinical stages up to commercial launch.
• Act as a Quality advocate and single point of contact for CMC program strategy teams.
• Ensure consistent quality approaches and deliverable completion for GMP manufacturing, testing, release, and regulatory filings.
• Proactively manage clinical product quality risks.
• Serve as Quality Assurance support and SME for clinical manufacturing.
• Chair Quality Subteams to align Operations Quality, External Quality, and QP on timelines and risks.
• Establish release strategies for new products.
• Review significant product-related deviations.
• Facilitate change controls.
• Support CMO selection and management.
• Serve as a Quality SME for regulatory submissions.

Benefits

• In-person working gives us the platform we need to connect, work at pace and challenge perceptions.
• Flexible working arrangements.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees