REQUIRED QUALIFICATIONS:
Knowledge of:
- FDA regulations related to biological products and cell therapy (Good Manufacturing Practices, Good Tissue Practices, etc.) as well as FACT, AABB, and WMDA standards.
- Quality systems and quality risk management.
- International quality management standards and guidance documents.
- Project management and business/management practices.
Ability to:
- Meet deadlines and manage multiple projects and tasks simultaneously.
- Understand unique client needs and translate into processes or services.
- Drive a results orientation utilizing strong problem-solving, decision-making and motivational skills to ensure alignment around goals.
- Collaborate cross-functionally and communicate effectively with internal and external stakeholders.
- Develop and lead strategic plans.
- Manage a diverse team of functions and roles.
- Build effective working relationships within an organization and with key stakeholders.
Education and/or Experience:
- Bachelor’s degree in biologic sciences, medical technology, business or related field.
- Minimum of 10 years of experience in a position that was responsible for quality management and compliance within a regulated environment (FDA GMP and/or GTP regulations).
- 5 or more years progressively responsible leadership experience.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Master’s or other advanced degree.
- Experience with FDA, FACT, and/or AABB inspections and accreditations.
DEI COMMITMENT:
As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.
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. Please reference this link for more information: NMDP Benefit Information
