Clinical Product Quality Lead

Introduction to role:

Are you ready to make a significant impact in the world of clinical product quality As a Clinical Product Quality Lead (CPQL) youll be at the forefront of ensuring the highest standards of quality from candidate selection through to commercial approval. Youll 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.