Associate Director, Quality Systems and Compliance

AstraZeneca • Rockville, MD

2d • Hybrid

About The Position

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.

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, and 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: Mid Level
• Number of Employees: 5,001-10,000 employees