Senior Manager Quality Assurance in Los Angeles, CA at Johnson Service Group

Date Posted: 9/20/2020

Job Snapshot

Job Description

JobID: 380399

Johnson Service Group, Inc has a great opportunity for a Senior Manager of Quality Assurance.  You will work cross functionally to assist with the qualification and monitoring program for medical apheresis and treatment centers that supports the companies commercially marketed cell therapy product. This position is remote and must be located on central or mountain time.

Responsibilities include (but are not limited to):

  • Assist in management of the collection application system.
  • Assess and approve any changes to collection application system, 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 qualification process using risk-based tools for qualification, training, monitoring and disqualification.
  • Collaborate with our Commercial operations in the routine management of the  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  list.
  • Assist with resolution of  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  management system (Oracle Agile)
  • Support inspection readiness plans and interact with regulatory agencies during inspections on related matters, as needed.
  • Ability to travel up to 40%
  • Remote position based in the Midwest, South, or Mountain areas of the country
  • Perform other duties as assigned

    Qualifications:
  • 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 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
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
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