Manager, Quality Operations

Role Overview

• Assess and approve any changes to Apheresis Collection Module, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.
• Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools for qualification, training, monitoring and disqualification.
• Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
• Perform a variety of audits, qualify and monitor compliance to qualification requirements.
• Maintain the monitoring schedule and approved ATC list.
• Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
• Support and/or own quality records (Deviations, CAPA, Change control, etc.)
• Assist in development, implementation and management of ATC management system (GVault)
• Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
• Ability to travel up to 40%

Requirements

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD
• Bachelor’s degree in biological sciences, nursing, medical technologist or related field
• 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles.
• Minimum 3-5 years quality assurance experience preferred
• Experience managing external suppliers, blood banks, and plasma centers.
• Medical center or pharmaceutical auditing experience preferred.
• Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
• Previous experience in deviation management, development of corrective preventive/actions and change control, preferred.
• ASQ Certified Quality Auditor preferred
• Strong working knowledge of and the ability to apply GMP and FACT/AABB standards
• Previous experience presenting and responding to regulatory agency or certification audits, preferred
• Proficient in MS Word, Excel, and Power Point
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Must be able to work independently, can multi-task and prioritize job responsibilities
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans.
• discretionary annual bonus
• discretionary stock-based long-term incentives
• paid time off