Quality Assurance Director jobs in the United States

Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Director Quality Control
  • 10000812 - Quality Assurance Associate Director
  • Rockville, MD FULL_TIME
  • Are you ready to lead and direct the Site Quality Control (QC) Operations at our Cell Therapy manufacturing facilities? We are looking for a dynamic leader who can develop strategic and operational plans to ensure the successful delivery of QC activities.  The Director Quality Control role requires innovative thinking within complex and ambiguous areas of the business. You will be leading other managers and providing strategic direction for the QC organization through a comprehensive understanding of global issues.

    What you will do:

    • Lead, create, and staff the new Quality Control organizational structure for the Commercial Cell Therapy Facility.

    • Partner with senior leaders across AstraZeneca to identify and remove blockers to ensure delivery of an integrated approach to Cell Therapy Quality across the business.

    • Oversight of all aspects of QC at the Cell Therapy Facility, potentially including testing of raw materials, in-process, viral vector, drug substance, drug product, stability, and microbiology samples in support of late-stage clinical and commercial programs.

    • Facilitate the growth and development of QC staff, demonstrate excellent communication skills through internal and external channels, support organizational objectives, and interpret company policies.

    Minimum Qualifications:

    • B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 8 years of applicable experience

    • M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

    • Minimum of 5 years of management experience

    • Minimum of 2 years of Cell Therapy/Biologics Quality Control experience including clinical lot release

    • Experience with product launches, health authority inspections, and global commercial product distribution requirements

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

    • Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.

    • Ability to influence senior stakeholders, both internally and externally

    Preferred Qualifications:

    • Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field

    • Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company’s values.

    • Experience with Cell Therapy regulatory inspections

    • Experience engaging with global regulatory bodies.

    • Proven track record of attracting and developing talent.

    • Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance

    At AstraZeneca, our work in Quality is important and valued. We are always innovating, and trialing the latest models and technologies to improve reliability and excellence in our processes. We take Quality seriously and draw learnings from others to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, and follow the science and evidence to make decisions that put patients first. We are a team of ambitious people who want to go far and we're all here to achieve. We are strong communicators and networkers. With constant exposure to different tasks, we're at our best when we're working together as a team.

    Are you ready to join a team where every voice is heard and matters? Apply now!

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

    AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

  • 9 Days Ago

1
Quality Assurance Associate Director
  • 10000093 - Quality Assurance Manager
  • Rockville, MD FULL_TIME
  • Join us at AstraZeneca as a Quality Assurance Associate Director, where you will be supporting and managing Site Quality Operations at Cell Therapy 9950 MCD. This role is pivotal in managing quality a...
  • 9 Days Ago

1
Director LabsQA/Audit Quality Assurance, R&D
  • 10001184 - Compliance Associate Director
  • Gaithersburg, MD FULL_TIME
  • Job Title: Director LabsQA/Audit Quality Assurance, R&D Quality AssuranceLocations: Office based with Flexibility in Waltham MA or Gaithersburg MDWhat are we offering?Do you want to join a dynamic tea...
  • 5 Days Ago

1
Quality Assurance Specialist IV
  • 10001152 - Quality Assurance Specialist
  • Gaithersburg, MD FULL_TIME
  • Introduction to Role:Join our dedicated team as a QA Specialist IV, providing Quality Assurance support to our Operations department. This role is perfect for those with a proven record as a Quality A...
  • 5 Days Ago

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Quality Assurance Validation Specialist
  • the ASSURANCE group
  • NJ, NJ FULL_TIME
  • Packaging Manufacturer of Cosmetics is seeking a Quality Assurance Validation Specialist to join their team. This position is primarily responsible for reviewing and overseeing the validations executi...
  • 24 Days Ago

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Quality Assurance/Batch Reviewer
  • The Assurance Group
  • Morris, NJ FULL_TIME
  • Packaging Manufacturer of Cosmetics is seeking a Quality Assurance \ Batch Reviewer to join their team. This position is primarily responsible for reviewing and overseeing the validations executions f...
  • Just Posted

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Director, Clinical QA (GCP) - Remote, US
  • Proclinical Staffing
  • Washington, DC
  • Proclinical are recruiting for a Director, Clinical QA (GCP) to join a biotech organisation. This role is on a permanent...
  • 3/29/2024 12:00:00 AM

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Director, Quality Assurance
  • Trace Systems
  • Vienna, VA
  • Overview: Job Title: Director, Quality Assurance Job Location: Tampa, FL or Vienna, VA Security Clearance: Active, in-sc...
  • 3/28/2024 12:00:00 AM

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Head Lifeguard
  • Onelife Fitness
  • Ashburn, VA
  • ** Head Lifeguard** **Job Category****:** Aquatics **Requisition Number****:** HEADL11787 Showing 1 location **Job Detai...
  • 3/28/2024 12:00:00 AM

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Director of Quality Control
  • ADAGE INNOVATIONS INC
  • Alexandria, VA
  • Job Description Job Description Benefits/Perks Competitive Compensation Great Work Environment Career Advancement Opport...
  • 3/27/2024 12:00:00 AM

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Quality Assurance Information Coordinator (Pharmacy)
  • Children's National Hospital
  • Washington, DC
  • Under the direction of the Chief of Pharmacy, Director of Pharmacy Operations, and the Manager of Pharmacy Informatics, ...
  • 3/26/2024 12:00:00 AM

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Quality Assurance Information Coordinator (Pharmacy)
  • Children's National Medical Center
  • Washington, DC
  • Under the direction of the Chief of Pharmacy, Director of Pharmacy Operations, and the Manager of Pharmacy Informatics, ...
  • 3/26/2024 12:00:00 AM

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Director, Quality Assurance
  • BuildSubmarines.com
  • Vienna, VA
  • Overview: Job Title: Director, Quality Assurance Job Location: Tampa, FL or Vienna, VA Security Clearance: Active, in...
  • 3/25/2024 12:00:00 AM

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Quality Specialist
  • CSL Plasma
  • Greater Landover, MD
  • Responsibilities: Mgr Center • Has overall authority for center operations production goals, monitor net yields, and imp...
  • 3/13/2024 12:00:00 AM

Income Estimation for Quality Assurance Director jobs
$160,765 to $202,784