Manager, Quality
NMDP
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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.
Requirements
- Bachelor’s degree in biologic sciences, medical technology, business or related field.
- 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.
- Knowledge of FDA regulations related to biological products and cell therapy (Good Manufacturing Practices, Good Tissue Practices, etc.).
- Quality systems and quality risk management.
- International quality management standards and guidance documents.
Benefits
- NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits.
- Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementcompliancechange controldocument controlinternal auditsvalidationssupplier managementCAPAquality risk managementquality systems
Soft skills
leadershipteam managementguidancesupportcommunication