QA Manager

Company: Talaris Therapeutics
Location: Louisville
Posted on: January 17, 2020

Job Description:

Talaris Therapeutics, Inc.("Talaris") is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a " Holy Grail " of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 - 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris has announced a $100M private financing from leading life sciences investors and has initiated a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients. We also expect to initiate two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA. The Quality Validation Manager is responsible for providing Quality oversight of Facilities and Equipment Quality Systems to ensure compliance with applicable US regulations, guidance's, industry standards and policies/procedures supporting the Phase I/II/III clinical and commercial GMP manufacturing of biological drug substance and drug product. The position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Facilities and Validation organizations.Reporting to the Head of Quality Assurance, the role will help lead the continued build-out of the Facilities, Equipment and Analytical Validation Program. The role will oversee the development of robust systems to support qualification and validation efforts of facilities, equipment, cleaning validation, methods, and processes. Key Responsibilities include but are not limited to:

• Serve as the QA liaison with the Facility, Engineering and Manufacturing organizations to support company goals, client projects, continuous improvement initiatives and as a general resource.
• Review and approve Protocols and Summary Reports for Equipment Installation/Operational/Performance Qualifications (IQ/OQ/PQ) used in the manufacture of cell banks, biological drug substance and parenteral drug product in a multi-product facility. Examples of equipment includes fermentors, bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves and critical utilities as well as Cleaning Verification (CV) Studies, Aseptic Process Simulation Studies, Sterilization Validations, Temperature Mapping Studies and other miscellaneous validation activities. Support review of the facility Validation Master Plan (VMP).
• Provide QA support of the Maintenance Program, including QA review and approval of Preventive Maintenance (PM) procedures ensuring their content and frequency are suitable for the intended application. Support other PM and responsive maintenance activities where needed.
• Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities.
• Develop and support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
• Perform other miscellaneous duties including assignment of equipment identification numbers, reviewing GMP engineering drawings, reviewing equipment relocation documentation and updating Equipment History Files.
• Support the program for quarantine and release of GMP cleanrooms in response to environmental disruptions to ensure facilities, utilities and equipment are acceptable for use in GMP manufacturing. Coordinate completion of applicable activities by Facilities, Operations, Quality Control and other applicable Quality Assurance functions.
• Provide QA support, including review and approval, for deviations and investigations related to facilities, equipment, equipment failures and environmental excursions ensuring events are contained, risks mitigated, impacts to equipment, product and processes adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented. Requires use of available Root Cause Analysis (RCA) tools such as Cause and Effect Diagram or Five Why's.
• Compile and submit pertinent QA metrics for periodic Senior Management review
• Perform periodic walk-throughs of Facility Critical Utility areas for HVAC, USP Purified Water Systems, Clean Steam Systems and Compressed Gas Manifolds to review logbooks, verify housekeeping and ensure equipment and utilities are adequately maintained.
• Support regulatory (FDA, EMA) inspections and client/Qualified Person (QP) audits.
• Support Internal Audit Program as needed.
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards.
• Experience with vendor audits
• Experience with facility design, commissioning, qualification, and start-up is a plus
• Ability to communicate well across different disciplines and experience levels.
• Experience supporting regulatory inspections
• Experience using risk management tools (FMEA, etc.)
• Design and maintain a robust Facility, Utility, and Equipment Qualification Program.
• Consult on Process and Cleaning Validation strategies.
• Draft, review, and approve various Validation related documents (including master plans, requirements documents, protocols, and reports).
• Support analytical vendor qualification and auditing
• Utilize expertise to educate organization on Validation best practices
• Quality Assurance approval authority of change controls and process and analytical validation documents assessing Impact Assessment, Action Plans, and Risk Assessment. Education & Experience:
  • Bachelor degree in a Science or technical related field (Engineering , Chemistry, Biology or with 8 years of experience - OR - Master's and 5 years
  • Experience supporting the quality assurance of validations associated to IQ, OQ & PQ's working primarily with the Facilities and Engineering teams for biologics manufacturing equipment.
  • Experience with aseptic processing
  • Must have experience with biologics
  • 5+ years of experience in a GXP environment and 5+ years working in Facility and Analytical Validation.
  • 1+ years of management experience.
  • Experience in the pharmaceutical, biotechnology, or gene therapy industry.
  • Expert Knowledge of IQ/OQ/PQ
  • Expert best practices for aseptic practices and contamination control
  • Experience leading Equipment Qualification Program
  • Experience in Cleaning Validation
  • Experience with Process Validation and Continuous Process Verification
  • Experience in GMP Environment
  • Experience with vendor audits
  • Experience with facility design, commissioning, qualification, and start-up is a plus
  • Ability to communicate well across different disciplines and experience levels.
  • Experience supporting regulatory inspections
  • Experience using risk management tools (FMEA, etc.) Talaris is an equal opportunity employer and prohibits unlawful discrimination.

Keywords: Talaris Therapeutics, Louisville , QA Manager, Executive , Louisville, Kentucky