Quality Systems Specialist (Radiopharmaceuticals)

Location: Everett, Washington, USA; onsite at the manufacturing facility. Travel required 10–20%.

Salary: $117,922–$176,883 per year, with eligibility for discretionary short-term incentive payments.

Company

hirify.global develops advanced nuclear technologies, while hirify.global Isotopes focuses on medical isotope production and radiopharmaceutical applications.

What you will do

• Author, revise, approve, and manage site quality policies and procedures.
• Support Quality Management Systems, including EDMS, LMS, training programs, Quality Risk Management, and data integrity policies.
• Develop and implement data integrity controls aligned with ALCOA+ principles and 21 CFR Part 11.
• Support supplier qualification, internal, customer, and supplier audits, including tracking corrective actions through closure.
• Support equipment, facility, and manufacturing-process validation and qualification activities.
• Provide quality training and guidance while collaborating with Quality Assurance, Operations, Quality Control, Engineering, R&D, Procurement, Project Management, and Commercial Services.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field, or equivalent experience.
• 6+ years of experience in a regulated production environment and 3+ years in a Quality Systems role.
• Experience working within Quality Systems and quality programs compliant with FDA/cGMP Title 21 CFR 210/211 and ICH Guidance.
• Strong knowledge of quality principles, regulatory interpretation, technical writing, and executive-level reporting.
• Ability to lead cross-functional teams, manage complex projects, adapt to changing priorities, and drive accountability.
• Ability to work safely in an onsite manufacturing environment, including prolonged work, stairs, extended sitting, and lifting up to 25 pounds.

Nice to have

• Experience in a production radiopharmaceutical facility.
• Certification in a pharmaceutical quality discipline, Lean Six Sigma, or project management.

Culture & Benefits

• Medical, vision, dental, life, disability, wellness, and gender affirmation benefits.
• 401(k) plan, parental leave, 21 accrued PTO days, and 10 paid holidays.
• Relocation assistance.
• Professional and educational support opportunities.
• Equal opportunity employment with workplace accommodations considered through an individualized assessment.