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Manager, QA/Regulatory Affairs

Description

UPMC Hillman Cancer Center is excited to be hiring a Full-Time Manager for QA/Regulatory Affairs! This will be a Monday through Friday, daylight position. 

The Manager, Quality Assurance/Quality Control (QA/QC) for Cellular Therapy will be responsible for implementation of the Quality Assurance/Quality Control Programs for CPL, IML and HSC laboratories at 350 Technology Drive in Oakland and at the Hillman Cancer Center in Shadyside. Responsibilities of this position include developing and implementing the quality assurance plan for the CPL, IML & adult and pediatric HSC labs and monitoring compliance with the appropriate Federal, State and accreditation agencies policies. The QA/QC Manager will develop and implement policies and procedures that are in compliance with applicable regulations and CLIA and cGLP/cGTP/cGMP requirements.

Responsibilities:

  • Assist the department Supervisors in the development of new SOPs for new equipment and as requested by Principal Investigators. Evaluate quality activities and coordinate with appropriate personnel including the Laboratory Supervisor to ensure identification, resolution, and tracking. Assist the Supervisor and Director in the development of Validation Plans for multiple pieces of equipment in the IMCPL and HSC, including initial plan, forms, initiation of projects and reports to ensure all regulatory requirements are met.
  • Ensure that policies, procedures and documentation systems are in place to assure continual conformance with Quality Assurance Plan. Assist in evaluating the effectiveness of the QM plan to meet FACT requirements. Develop, implement and direct an Internal Audit Program and identify areas for quality improvement. Develop plans for continuous quality improvement (CQI) and recommend quality initiatives for CPL, IML and HSC laboratory facilities. Direct the Standard Operating Procedure (SOP) management system and oversee SOP preparation. Assist with establishing and maintaining a document control and filing system for all QA/QC source documents and reports within the respective department.
  • Identify areas of potential non-compliance and work with laboratory Supervisor and Director to implement remedial action plans. Assist in preparation for laboratory inspections for CAP, FDA, FACT and the PA Department of Health. Conduct mock-inspections to assess readiness. Plan, organize, conduct, and document quality reviews and testing programs.
  • Review QA/QC data, technical reports, equipment records and other data including laboratory testing results. Participate as required in the development and maintenance of departmental outreach activities within and outside of the Department of Pathology, in the development of reference clinical testing, clinical trials, and in support of joint ventures. Assist in the preparation of Biological Product Deviation Reporting to the FDA Center for Biologics Evaluation and Research.
  • Education: Preparation and presentation of in-services designed to foster awareness and increased compliance with QA initiatives. Schedule various technical webinars from regulatory agencies for continuing education. Monitor Laboratory Information System development: Ensure adequate and appropriate documentation of validation and production, adherence to 21 CFR 11. Participate, as appropriate, in preparation of presentations for scientific meetings, publications, or in the preparation of materials to promote
  • Preparation of Master File submissions to the FDA for the IMCPL, the Adult HSCLab and the Pediatric HSCLab. Assistance in preparation of CMC sections and IND submissions to the FDA for the IMCPL, the Adult HSCLab and the Pediatric HSCLab.
  • Develop, implement and maintain the QA and QC Programs. Implement the documentation, monitoring and auditing systems in support of Quality Assurance Plan. Establish Quality measurements and bench marks, and perform trend analysis as appropriate to identify possible non-conformities and areas of improvement. Establish quality standards relating to QA/QC to ensure that the organization meets applicable State, Federal and accrediting agency regulatory requirements. Actively monitor changes in the Federal regulations and other accrediting agencies standards to ensure continued compliance with current regulations and standards. Maintain competency and strive to meet requirements to become a CAP and/or FACT inspector . Participate in FACT and CAP inspections.
  • Departmental or UPMC's programs. Attend scientific meetings as budgets permit to expand knowledge base Serve as an expert liaison when accreditation or regulatory issues arise across the University or UPMC.Conduct mock inspections for CAP and FACT standards and Federal Regulations to assess laboratory preparedness for the IMCPL, Adult HSCLab, Pediatric HSCLab, Dr..

 

Qualifications

  • A minimum of a BS degree in laboratory science or related field.
  • Minimum of 3-5+ years of experience in QA or regulatory compliance in a clinical or service laboratory.
  • Knowledge of GLP, GTP, GMP, CLIA, OSHA, CAP, AABB, FACT, and other regulations and standards applicable to a licensed laboratory.
  • Good computer skills with prior knowledge and proficiency in using MS Office (Word, Excel, PowerPoint).
  • A high degree of independence and judgment.
  • Good organizational skills.
  • Excellent interpersonal skills; the ability to communicate effectively orally and in writing is essential.


Licensure, Certifications, and Clearances:

  • Act 34

  • UPMC is an Equal Opportunity Employer/Disability/Veteran

Total Rewards

More than just competitive pay and benefits, UPMC’s Total Rewards package cares for you in all areas of life — because we believe that you’re at your best when receiving the support you need: professional, personal, financial, and more.

Our Values

At UPMC, we’re driven by shared values that guide our work and keep us accountable to one another. Our Values of Quality & Safety, Dignity & Respect, Caring & Listening, Responsibility & Integrity, Excellence & Innovation play a vital role in creating a cohesive, positive experience for our employees, patients, health plan members, and community. Ready to join us? Apply today.

   Current UPMC employees must apply in HR Direct