Clinical Product Quality Lead

AstraZeneca•New Haven, CT

1d•Hybrid

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? Accountabilities: As a CPQL, you will provide quality oversight for various clinical products across different presentations, from pre-clinical stages up to commercial launch. You will act as a Quality advocate and single point of contact for CMC program strategy teams, ensuring consistent quality approaches and deliverable completion for GMP manufacturing, testing, release, and regulatory filings. Your role involves proactively managing clinical product quality risks, serving as Quality Assurance support and SME for clinical manufacturing, and chairing Quality Subteams to align Operations Quality, External Quality, and QP on timelines and risks. You will establish release strategies for new products, review significant product-related deviations, facilitate change controls, support CMO selection and management, and serve as a Quality SME for regulatory submissions. Essential Skills/Experience: 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 (essential) 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. Successful candidates will 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. Desirable Skills/Experience: Prior experience with combination products. 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, we are driven by a passion to innovate and create meaningful value in all we do. Our culture is rooted in integrity and inclusiveness, empowering us to make a difference where it truly counts. With a rapidly expanding portfolio and an entrepreneurial spirit, we offer an environment where you can grow and explore new ideas that profoundly impact patients' lives. Join us in our mission to change lives for the better every day. Ready to take the next step in your career? Apply now and become part of our dynamic team!

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 (essential)
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.
Successful candidates will 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, ensuring 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.