Site Quality Director

Location
Louisville, KY
Posted
Jun 09, 2021
Ref
1028
Required Education
Masters Degree/MBA
Position Type
Full time
Job Title: Site Quality Director

Schedule: Full-time

Location: Louisville, KY

Classification: Salaried, Exempt

Reports to: Vice President, Quality Assurance

Direct Reports:Yes

Position Summary:

The Site Quality Director is responsible for providing leadership to the site Quality organization, including Quality Assurance and Quality Control, and for the development, maintenance, and oversight of the Talaris Louisville site Quality Management Systems. The Site Quality Director will develop and oversee robust and sustainable quality systems that ensure that Talaris’ manufacturing and quality control activities are conducted in compliance with FDA and EMA current Good Manufacturing Practices (cGMP). These systems will ensure the safety, efficacy, reproducibility, and purity of the products manufactured by Talaris. This position is based in Louisville, KY.

Principal Duties and Responsibilities:

The following is a summary of the significant functions of this individual's job. He/she may perform other duties, both major and minor, which are not mentioned below, and specific services may change from time to time.
  • Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team
  • Develop the site Quality strategy and support the site leadership team on developing site strategic plans aligned to corporate strategic objectives; foster a site-wide quality culture
  • Oversee the activities of the Talaris Louisville Quality department, ensuring compliance with cGMP, cGTP and other applicable regulations
  • Implement and maintain site GxP systems and compliance infrastructure; manage and report key performance metrics
  • Accountable for all aspect of Quality Control including analytical, specifications, sample management, stability, LIMS, raw material, and microbial (EM, PM, sterility) testing.
  • Plan and assign projects to meet departmental and organizational objectives
  • Implement best practices with respect to aseptic cell therapy manufacturing.
  • Interact effectively with regulatory, IT, facilities, and manufacturing staff to build consensus on approaches to ensure that regulatory requirements are met.
  • Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions.
  • Provide input on, and ensure regulatory compliance of, Talaris’ training programs
  • Ensure that QA activities are managed in accordance with available budget, resources, and personnel
  • Approve project schedules and any deviation from schedules
  • Oversee root cause analysis of material non-conformance events and deviations
  • Lead and manage manufacturing site inspections by regulatory agencies
  • Review and approve technical and regulatory reports, new SOPs, and significant SOP revisions
  • Maintain substantial current technical knowledge related to all procedures relevant to Talaris technologies in development


Location; Travel: This position is based in Louisville, KY and will require only minimal travel.

Minimum Education, Training, and Experience Required:
  • PhD or MS preferred, in the biologic sciences or related field, with greater than 10 years leadership experience and technical experience in quality systems.
  • Thorough understanding of the field of cell therapy processing and cryopreservation
  • Experience as a functional head of a quality department
  • Prior experience implementing and managing quality systems within a cGTP/cGMP regulated biotech or pharmaceutical company
  • Thorough understanding of FDA and EMA GMP regulations and experience in handling regulatory inspections
  • Demonstrated ability to effectively set and prioritize departmental goals
  • Excellent time management and organizational skills
  • Demonstrated ability to collaborate well with cross-functional colleagues
  • Demonstrated ability to manage and develop junior QA staff
  • Excellent written and verbal communication skills


Additional Qualifications
  • Exceptional analytical skills
  • Pragmatic, solutions-oriented approach to problem-solving
  • Proficient in Microsoft Word, Excel, PowerPoint and other relevant applications
  • Experience implementing and administering an electronic QMS preferred
  • Ability to work effectively in a fast-paced, rapidly changing, small company environment


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, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, 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. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.