Associate Director, Quality Systems and Compliance

AstraZeneca • Rockville, MD

1d • Hybrid

About The Position

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.  In essence, we are the critical link that brings innovation from our science labs to patients around the world.  From our quality labs to commercial manufacturing, we share a common purpose to ensure our high-quality medicines reach patients when and where they need them, with the ultimate goal of improving their daily lives.  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.  Across our R&D and manufacturing organizations, we are investing in internal capabilities to help us realize our ambition to discover and deliver next-generation cellular therapies. Demonstrating institutional expertise in biologics engineering, gene editing and immunology, we are uniquely positioned to develop innovative technologies to advance cell therapies in the treatment of disease areas with high unmet medical needs. About Rockville Manufacturing Center (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.  Our Rockville Manufacturing Center (RMC) cell therapy facility located in Rockville, Maryland is the newest addition to our global supply network of nearly 30 manufacturing and supply facilities in 16 countries. This manufacturing facility aims to make a direct contribution and immediate impact to patients by delivering life-saving cell therapies. It’s exciting and highly rewarding work, involving hundreds of dedicated people throughout the manufacturing lifecycle along with supporting office functions.   Every day at AstraZeneca we work hard to deliver life-changing medicines to patients, along with taking time to have fun and celebrate our accomplishments. From catered site festivities to driven events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements. 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 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 new ground and 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. Accountabilities: As the Quality Systems & Compliance Associate Director, Cell Therapy, you will provide leadership, direction and mentoring to ensure that the QS/C organization 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 Organization 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.

Requirements

• 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 prioritize work

Nice To Haves

• 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

Responsibilities

• provide leadership, direction and mentoring to ensure that the QS/C organization is successful in meeting the quality and manufacturing objectives in support of site goals
• represent the QS/C department and/or the Quality Organization on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure results are aligned with site business objectives
• 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
• demonstrate excellent communication skills through internal and external channels

Benefits

• Benefits offered included 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees