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POSITION SUMMARY:
This role is responsible for the management of the NMDP BioTherapies quality unit and for developing strategic direction for quality and regulatory support of NMDP BioTherapies. This role assesses, develops and effectively manages quality systems and processes critical for NMDP BioTherapies, in collaboration with other NMDP QRA teams. This is a remote position (US). #LI-Remote
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ACCOUNTABILITIES:
Strategy and Direction:
- Works with senior leadership to develop and execute strategies to provide comprehensive quality support for NMDP BioTherapies’ operations groups, clients, and partners, in support of the organization’s strategic plan.
- Works with Quality department and operations leaders to analyze, plan, and improve enterprise quality systems and compliance.
Leadership:
- Provides expertise, guidance and executional support to business partners, project teams, and clients.
- Plans, identifies, and develops staffing needs for highly effective team performance.
- Leads quality system development and process improvement projects.
- Provides coaching, direction and support for team members.
Quality Management:
- Implements, evaluates, and improves Quality Management System and key supporting processes to maximize efficiency and efficacy for NMDP BioTherapies
- Coordinates preparation for and management of audits by regulators, accrediting agencies, and NMDP BioTherapies’ clients.
- Supports and collaborates with other Quality leaders and process owners to develop consistent and integrated quality processes across the organization.
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
