Manager, Analytical Sciences Quality

Job Title: Manager, Analytical Sciences Quality

Introduction to role

Are you ready to lead and innovate in the field of Analytical Sciences Quality? As the Manager, Analytical Sciences Quality, you will provide essential quality partnership and oversight to the Product Development and Clinical Supply (PDCS) Analytical Quality Control Laboratory teams at our New Haven site and CLO/CMOs. Your role will be pivotal in ensuring quality oversight of internal and external testing, stability, and analytical technical transfer. Additionally, you will be responsible for GMP compliance and inspection readiness for the QC laboratories. Are you prepared to make a significant impact?

Accountabilities

- Act as a Quality team member responsible for reviewing technical documents, analytical method transfers, and validation for Phase I to III clinical products.
- Manage assay validation and transfer programs internally and externally.
- Review and approve stability reports, analytical development, and verification reports.
- Perform data verification on CMC sections for filings based on technical reports.
- Provide Quality support for QRM activities (risk assessments in support of ADQC).
- Partner with the Compliance team to manage the timely completion of QMS records (Change Controls, Deviations, LIRs, and CAPAs) aligned to global quality metrics goals.
- Assess data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs.
- Serve as a Quality approver for Clinical Product Specifications (methods, SOPs).
- Support analytical lifecycle management initiatives.
- Collaborate with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, recalls, etc.
- Lead and support inspection readiness activities.
- Demonstrate agility and adaptability.
- Provide Quality support for laboratory software validation, equipment qualification, and periodic review.

Essential Skills/Experience

- 10+ years of cGMP experience within quality in a biotech, pharmaceutical, or biopharmaceutical manufacturing environment, pre-clinical phases through commercial.
- Experience with direct quality oversight of an analytical laboratory.
- Prior experience with method validation, including combination products.
- Demonstrated ability in decision making, problem solving, and project management.
- Ability to collaborate, negotiate, influence, and lead in a matrix organization.
- Excellent communication and interpersonal skills.
- Knowledge of quality systems with strong business and technical acumen required.

Desirable Skills/Experience

- Prior experience with cell & gene therapy products.

At AstraZeneca, we are driven by our passion for science and innovation. We are committed to exploring new horizons by integrating data and technology with scientific advancements to tackle some of the world's most complex diseases. Our inclusive environment fosters collaboration across academia, biotech, and industry, empowering us to make bold decisions and celebrate both successes and failures. With a focus on lifelong learning and growth, we offer numerous opportunities to develop your career while making a meaningful impact on patients' lives globally.

Ready to join a team that is pushing the boundaries of science? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.