Quality Assurance At-the-SourceLead, Cell Therapy

Are you ready to foster an attitude of excellence? Join AstraZeneca's Global Quality Operations teamas a Quality Assurance At-the-Source (ATS)Lead, Cell Therapy at the Rockville Manufacturing Center (RMC) facility, the newest addition to our global supply network.We aim to make a direct impact on patients by delivering life-saving cell therapies.This is your chance to break newgroundand leave a collective legacy! We are investing in internal capabilities across our R&D and manufacturing organizations to help us realize our ambition to discover and deliver next-generation cellular therapies.

Why Join Quality?

In Quality, our work is important and valued. An unrivalled forward-looking mindset,there’sno better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. As the voice of the patient, every batch wework onis a personal stamp of approval. Not something we takelightly,we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes. A place to take Quality seriously – we draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Hereyou’llfeel empowered to step up, follow the science and evidence to make decisions that put patients first.If you have the passion and the drive to accelerate growth and make people’s lives better – then this is the place for you.

Whatyou’lldo:

As aQA ATSLead, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  The individual assures the quality and compliance for commercial and clinical products manufactured at the facility.

Responsibilities:

• Supports team membersbyfacilitatingscheduling and personnel coordination, removingroadblocksand mentoring in complex situations.

• Reads, understands, and follows SOP’s andcomplies withcGMP

• Writes and/or revisesQuality documentationutilizingelectronic document management systems

• Supports the evaluation and disposition of labelling, raw materials,intermediatesand finished products throughtimelyevaluation of batch records, laboratoryresultsand other cGMP documents

• Supports the issuance and reconciliation of cGMP documentation

• Reviews and/or approves executed batch records, equipment logs, etc.

• Supports internal audits of manufacturing, analytical testing, labeling, etc. to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program

• Supports continuous improvement efforts

• Participates in cross-functional Tier meetings

• Ability to work "off-hours" as needed to support release ofproductto meet patient dosing needs

• Creates and manages deviations, change controls, and CAPA recordspertaining totheir functional areas in the Electronic Quality System

• Assistswith deviation investigation and root cause analysis

QAATSLeadRequired Education and Experience:

• 7+ years applicablequality experiencewith B.S. degree in Science, Engineering, or related technical field

• 11+ years applicable withAssociatesdegree

• 15+ years applicable with High School Diploma

• Experience writing and investigating quality records

• Proven ability to work in a fast-paced environment across multiple technical functions

• Strong knowledge ofcGMPs

• Demonstrated ability to make decisions under pressure that balance patient safety,complianceand supply  

Preferred Experience:

• M.S degree in Science,Engineeringor related technical field

• Autologous cell therapy manufacturing or quality experience

• Working knowledge of international Cell TherapyGxPregulatory frameworks,regulationsand guidance

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This meanswe’reopening new ways to work, groundbreakingcutting edgemethodsand bringing unexpected teams together.Interested? Come and join our journey.