Apply at: https://nusano.com/careers/now-hiring/?ashby_jid=8c730699-2a03-4555-b500-ecefd2cde4af
At Nusano, Quality is a fully integrated function, supporting development through commercialization. The Quality Systems Manager advances quality systems and ensures compliance with FDA and cGMP regulations for isotope production used in the diagnosis and treatment of cancer. In this role, you will play a critical role in driving a culture of quality, risk management, and inspection readiness across the Quality Management System (QMS).
Responsibilities
What you'll do:
Leadership and Engagement
- Lead and develop QA staff while aligning with Quality and company leadership
- Drive a culture of quality, compliance and inspection readiness throughout the organization
Quality Assurance Systems
- Oversee controlled documents (SOPs, policies, forms, templates) and ensure proper review, approval, distribution, and archival.
- Manage records retention schedules in compliance with applicable regulations.
- Develop and manage training programs, curricula, and tracking systems.
- Ensure training compliance and maintain training records for all GxP staff.
- Administer and review change requests, ensuring proper impact assessment, approvals, and timely closure.
- Oversee CAPA, deviations, and nonconformances, ensuring timely investigation, resolution, and effectiveness
- Act as system owner for eQMS platforms, including deployment, validation, and periodic review.
- Drive continuous improvement initiatives to enhance efficiency and compliance across QA processes.]
- Support supplier and vendor qualification activities in collaboration with Quality Manager.
Qualifications
Minimum requirements:
- Bachelor’s degree in life science (e.g. chemistry or biology)
- 7+ years of Quality Assurance experience in a GMP-regulated environment, including 3+ years in leadership
- Ability to manage multiple priorities and work in a fast-paced environment.
- Proficiency in Microsoft Office
- Strong verbal and written communication skills
- Experience with various stages of product life cycles (pre-commercial/post-commercial)
- Experience with eQMS deployment and management
- Experience interfacing with engineering, chemistry/laboratories, product development, technical operations