31 applicants

Company

Original Job Post

AstraZeneca · 2 days ago

Associate Director of Quality Engineering

Rockville, MD

Full-time

Onsite

Director

8+ years exp

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Comp. & Benefits

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Responsibilities

Provide oversight of Quality Risk Management, CQV, and CSV programs for the Cell Therapy operation at the Rockville Manufacturing Center

Lead the technical quality arm of the Quality department

Manage resource planning, shift structure design, and organizational assignments

Develop and mentor staff focusing on planning, communication, leadership, teamwork, problem-solving, performance management, and talent development

Ensure operations are aligned with cGMP standards and relevant regulatory agencies

Qualification

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Quality EngineeringProduct LaunchesHealth Authority InspectionsGlobal Commercial Product DistributionPatient SafetyComplianceSupply Chain ManagementProblem-SolvingDecision-MakingInfluencingProject ManagementScienceBiochemistryPharmacyRegulatory InspectionsGlobal EngagementGxP Regulatory FrameworksInternational RegulationsCell TherapyLeadershipChange ManagementTalent Development

Required

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 2 years of Cell Therapy/Biologics Quality Engineering experience

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

Proven track record of working 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 collaborators, both internally and externally

Preferred

Minimum of 2 years of management/supervisory/project management experience preferred

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

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

Experience with Cell Therapy regulatory inspections

Experience engaging with global regulatory bodies

Consistent track record of attracting and developing talent

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

Company

AstraZeneca

Glassdoor

4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor AB.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10,001+ employees