# Associate Director, Quality Systems and Compliance **Company**: Quality Cell Therapy **Location**: Rockville, Maryland, United States of America **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Salary**: $129,556.80 - $194,335.20 USD Annual **Category**: Engineering **Industry**: Biotechnology **Apply**: https://astrazeneca.eightfold.ai/careers/job/563877689842338 **Canonical**: https://yubhub.co/jobs/job_904b9845-2ff ## Description About Cell Therapy: In Operations, we turn molecules into medicine and are unified in our commitment to deliver more medicines to more patients more quickly. We are the critical link that brings innovation from our science labs to patients around the world. We're achieving all of this while continuing to accelerate our operational excellence through innovative science, Lean ways of working, and evolving digital technologies. Using cell therapy to halt and reverse disease, restore damaged organs, and, ultimately, cure many life-threatening conditions is now a realistic goal for our scientists and operators. About Rockville Manufacturing Centre (RMC): Our role in Operations is to bring these promising therapies from the lab to life through a thorough process of development, manufacturing, testing and supply. Our fast-paced, growing environment provides a wealth of opportunity and global opportunities to learn from other teams, embrace lifelong learning and build capabilities, setting your own direction and pace for your long-term career. Introduction to role: Are you ready to develop an attitude of excellence? Join AstraZeneca's Operations team as the Quality Systems & Compliance Associate Director, Cell Therapy at the Rockville Manufacturing Centre (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 new ground and leave a collective legacy! Accountabilities: As the Quality Systems & Compliance Associate Director, Cell Therapy, you will provide leadership, direction and mentoring to ensure that the QS/C organisation is successful in meeting the quality and manufacturing objectives in support of site goals. You will represent the QS/C department and/or the Quality Organisation on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure results are aligned with site business objectives. You will facilitate the growth and development of QS/C staff, provide strategic support to the Quality Site Lead, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels. Essential Skills/Experience: - B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience - Minimum of 2 years of management/supervisory/project management experience - Experience in audit and inspection management - Consistent record of working in a fast-paced, cross-functional work environment - Excellent written and verbal communication skills - Team oriented approach to project management and problem resolution - Proven record of making decisions that balance patient safety, compliance, and supply - Ability to influence senior collaborators, both internally and externally - Ability to multi-task and prioritise work Desirable Skills/Experience: - M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience - Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field - Experience with Quality Systems (e.g. Veeva Vault) is desirable. - Experience with Cell Therapy regulatory inspections - Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance. - Experience engaging with global regulatory bodies - Consistent track record of attracting and developing talent Benefits: AstraZeneca offers a competitive salary range of $129,556.80 - $194,335.20 USD Annual, a short-term incentive bonus opportunity, eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include a qualified retirement program (401(k) plan), paid vacation and holidays, paid leaves, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an 'at-will position' and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At AstraZeneca, we champion a perspective of excellence. Our environment is driven by a belief that good can always be better. We continuously seek opportunities to contribute by harnessing science and evidence to foresee risks. It's a place where innovation thrives as we focus on delivering life-changing medicines to patients. ## Skills ### Required - B.S. degree in Science, Engineering, Pharmacy, or related technical field - Minimum of 5 years of applicable experience - Minimum of 2 years of management/supervisory/project management experience - Experience in audit and inspection management - Consistent record of working in a fast-paced, cross-functional work environment ### Nice to have - M.S. degree in Science, Engineering, Pharmacy, or related technical field - Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field - Experience with Quality Systems (e.g. Veeva Vault) - Experience with Cell Therapy regulatory inspections - Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance.