Manager, Quality

NMDP • Minneapolis, MN

1d

About The Position

POSITION SUMMARY: Manages daily operations of Quality Assurance staff; implements and maintains enterprise quality system in support of strategic plan. Provides support and guidance to the organization regarding quality system and compliance with cell therapy regulations. Responsible for oversight of enterprise Quality Management software platform. ACCOUNTABILITIES: Implement and Maintain Quality System: 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. Lead and Manage: 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.

Requirements

• 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 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.
• Education and/or Experience: 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.

Nice To Haves

• Knowledge and experience with software validation within regulated environments.
• Knowledge of HIPAA and privacy regulations.
• Knowledge or experience with electronic signatures and FDA Part 11 requirements.

Responsibilities

• Manages daily operations of Quality Assurance staff
• Implements and maintains enterprise quality system in support of strategic plan
• Provides support and guidance to the organization regarding quality system and compliance with cell therapy regulations
• Responsible for oversight of enterprise Quality Management software platform
• 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.

What This Job Offers

• Career Level: Manager
• Number of Employees: 1,001-5,000 employees