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NMDP · 10 hours ago

Manager, Quality

United States

Full-time

Remote

Mid, Senior Level

5+ years exp

NMDP is a leader in cell therapy and is seeking a Manager of Quality to oversee the daily operations of their Quality Assurance staff. This role involves implementing and maintaining the enterprise quality system, ensuring compliance with cell therapy regulations, and managing the quality management software platform.

Health CareHealth DiagnosticsMedicalMedical Device

Comp. & Benefits

Responsibilities

Develops, improves and/or maintains processes and procedures for essential quality system elements, including change control, document control, internal audits, validations, supplier management, management reports, complaint and problem investigation/CAPA, etc

Evaluates business needs and ensures efficient and appropriate implementation of quality management software; proposes and manages changes, enhancements, and implementation of new functions

Leads and manages high-performing team responsible for internal audits, quality system reporting, change control oversight and approval, deviation and CAPA approval, validation oversight, and other QA functions

Provides support and guidance to business units and project teams regarding quality system and compliance with cell therapy regulations

Other duties as assigned

Qualification

FDA regulationsQuality managementQuality risk managementSoftware validationInternational quality standardsCommunication skillsTeam collaborationProject management

Required

Knowledge of FDA regulations related to biological products and cell therapy (Good Manufacturing Practices, Good Tissue Practices, etc.)

Knowledge of quality systems and quality risk management

Knowledge of international quality management standards and guidance documents

Ability to meet deadlines and manage multiple projects and tasks simultaneously

Ability to work effectively both independently and as part of a team

Ability to communicate effectively, both orally and in writing

Ability to build strong relationships and collaborate cross-functionally

Ability to stay up to date on federal, state, and international regulations applicable to NMDP activities

Bachelor's degree in biologic sciences, medical technology, business or related field. Upon evaluation, Associate's degree with 10 or more years' progressively responsible experience in quality management within a regulated environment may be substituted

5 or more years of experience in a position that was responsible for quality management and compliance within a regulated environment (FDA GMP and/or GTP regulations)

2 or more years' supervisory experience