Manager, Analytical Sciences Quality
Manager, Analytical Sciences Quality
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1 Vacancy
Job Description
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 worlds 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!
Date Posted
27-May-2025Closing Date
27-Jul-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in E-Verify.Required Experience:
Manager
Employment Type
Full-Time
