Quality Management Systems Manager

Location
Louisville, KY
Posted
Apr 25, 2021
Ref
1011
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Job Title: Quality Management Systems (QMS) Manager

Schedule: Full-time

Location: Louisville, KY

Reports to: Senior Manager, Quality Assurance

Direct Reports:N/A

Position Summary:

Quality Management Systems (QMS) Manager is responsible for the administration, support, and maintenance of the Veeva electronic quality systems that are owned by Quality, including Document Management, Training Management, and Quality Management Systems. Duties include but are not limited to: System administration operations such as managing and configuring workflows and parameters to support business needs, managing end-user system access, developing and issuing reports, addressing system issues, providing technical support to end users on all Veeva processes, providing documentation support to all operations and maintaining all document related systems, ensuring compliance to 21 CFR 210/211, 21 CFR Part 11, and 21 CFR 1271. This position is critical to support the implementation, use, and maintenance of Veeva.

Principal Duties and Responsibilities:
  • Building, managing, and administering the company’s Document Management (DMS), Training Management (TMS), and Quality Management Systems (QMS).
  • Administering Veeva Management Systems for all users and ensuring compliance with established procedures.
  • Enhancing existing procedures, and creation of new best practices will be a critical component of this role.
  • Assisting in the administration and improvement of the company’s document and record management program.
  • Leading the QMS Program, specifically the deviation, CAPA, & change control programs
  • Developing, improving, and administering the QMS Programs. Contribute in developing optimum future state of QMS for business needs
  • Acting as Veeva business administrator for DMS, TMS, and QMS
  • Providing subject matter expertise to improve the Systems
  • Developing and improving Quality department procedures
  • Training new users on Veeva systems and processes
  • Ensuring compliance with approved company procedures as they relate to the creation and approval of documents and records
  • Coordinating periodic review of DMS, TMS, and QMS records
  • Generating metrics to regarding process performance and presenting to management
  • Meeting with DMS, TMS, and QMS record owners and participants to ensure proper system usage
  • Performs other duties as assigned.


Secondary Responsibilities:
  • Supporting internal and external audits related to the DMS, TMS, and QMS
  • In a project environment, contribute to the development and/or modification of Document, Training, and Quality Management Systems.
  • Proficiently take part in information systems discussions as required. Thinks about all Management Systems from an IT perspective, including proficient contributions to SRS/URS requirements.
  • Key contributor to the business process(es) and understands how IT system supports those business processes
  • Supports the business during audits to discuss system functionality.
  • Has knowledge of the system integrations
  • Supports the Business Process Owner/QA approver in IT change control assessment and approval on behalf of the business, with understanding of change control requirements per regulatory and internal procedural requirements.
  • Working to develop and imbue a Quality Culture particularly with regards to managing Quality Systems-associated documents and records.


Minimum Education, Training, and Experience Required:
  • Bachelor’s degree in a technical discipline is required
  • Minimum of 6 years’ experience in related Biopharmaceutical QMS roles.
  • Experience in Biopharmaceutical QA and/or Quality System improvement roles.
  • Working knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, ICH Guidelines and EU GMPs as well as knowledge of 21 CFR Part 1271 and EU ATMP regulations.
  • Strong organizational skills and attention to detail
  • Strong interpersonal skills
  • Ability to provide subject matter expertise regarding QMS implementation and administration
  • Systems Administration experience
  • Experience with Gene Therapy / Cell Therapy products preferred
  • Previous experience with electronic DMS, TMS, and QMS systems required; experience with Veeva preferred
  • Computer System validation experience
  • Veeva Administrator Certification or equivalent system certification is preferred
  • Detail-oriented team player with effective planning, organization and execution skills.
  • Excellent verbal and written communication skills.
  • Strong computer skills with Microsoft 360 applications.
  • Ability to work effectively at a fast pace with cross-functional departments.
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.


Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift 15 pounds at times.
  • Must be able to access and navigate each department at the organization’s facilities.


Benefits:
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off 25 days
  • Stock Options
  • 401k


Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. 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 2009 – 2016, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant, without rejecting their donated organ. The benefits of our therapy have been shown to be extremely durable. We have followed these patients for an average of over five years since their transplant, and the longest for over ten years, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. Since late-2018, Talaris has raised over $190M in private financing from leading life sciences investors and has initiated a Phase 3 registration trial of our therapy in living donor kidney transplant patients. In 2021, the company also plans to initiate Phase 2 trials of FCR001 in scleroderma as well as in patients who have previously received a living donor kidney transplant. Our cell processing facility is based in Louisville, KY, and we have a corporate office in Boston, MA