Senior Director, Global Quality

DISCGENICS INC•Salt Lake City, UT

About The Position

Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment. At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort. Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do. Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past. Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies. Lead Global Quality Excellence at DiscGenics! Are you ready to make a global impact in the rapidly evolving world of regenerative medicine? DiscGenics is seeking a Senior Director, Global Quality to champion quality across our organization and shape the future of patient care. In this pivotal role, you’ll serve as the Management Representative and Head of Quality, overseeing Quality Assurance, Quality Control, and Microbiology functions. Reporting directly to the CEO, you’ll drive the implementation and continuous improvement of a globally compliant Quality Management System (QMS) that supports clinical trials, cGMP commercial manufacturing, and regulatory filings for global market approvals. As a strategic leader, you’ll: Build and mentor a high-performing quality team. Ensure compliance with international regulations and standards. Foster a culture of collaboration, integrity, and innovation aligned with DiscGenics values. Lead initiatives that enhance organizational effectiveness and employee engagement. This is your opportunity to influence quality at every level, deliver life-changing therapies, and help shape a culture of excellence. Ready to lead with impact? Join us and be part of something extraordinary.

Requirements

Experience with 21 CFR 211 and/or 21 CFR 820 and/or 21 CFR 1271
Familiarity and experience with International Conference of Harmonization (ICH) guidelines
Experience performing internal and/or external audits
Able to proactively identify quality gaps, and implement appropriate solutions that consider the needs of all company departments
Strong communication and technical writing skills
Impeccable attention to detail
Team leadership skills and team player
Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship.
Regular and predictable attendance.
Ability to report to work unimpaired
Minimum 8-10 years’ experience in Quality Management in life sciences (directly in cell therapy, biologics, or other related biopharma sectors), with specific successful management experience in building and successfully implementing a QMS.
Minimum bachelor's degree in relevant field, advanced degree preferred.

Nice To Haves

Considerable experience with successful eQMS and/or other Quality information system RFP process, contract negotiations, implementation, and roll out.
Considerable experience with cell therapy comparability research and other forms of testing/analysis inclusive of release testing (including potency assay development) and stability testing preferred.
Considerable experience in cell therapy cGMP manufacturing for both late-stage and clinical and commercial launch preferred (inclusive of BLA submission and approval).

Responsibilities

Serve as Management Representative for DiscGenics, including facilitation of Management Review. Identify trends in quality metrics to assess the effectiveness of the QMS and devise plans to improve quality systems.
Develop and fully implement a Quality Management System that is compliant with FDA and applicable global market regulations.
Navigate multiple regulatory requirements including FDA 21 CFR Parts 210/211, 600-680, 820, and 1271, Japan PMDA regulations, and ICH guidelines.
Fully implement an electronic quality management system (eQMS) and/or other Quality information system to support compliance of quality systems.
Establish and maintain design control, quality by design (QBD), and risk management programs.
Qualify raw materials and components and their suppliers, and ensure quality agreements are in place.
Oversee adherence to quality system, manufacturing batch records/SOP’s, and applicable in-process and final safety and release testing for IDCT cGMP dose manufacturing.
Responsible for ensuring that documented evidence exists that demonstrates the conformance of products to pre-defined specification criteria and for release of such products.
Execute external quality audits of suppliers as required per internal procedures.
Supports clinical trial execution compliance to the appropriate SOP’s for both DGx and CRO vendors.
Responsible for document control, internal quality audits, complaint and corrective action systems, supplier quality, and training.
This individual is responsible for control of nonconforming products including their segregation, quarantine, disposition, and disposal, and is the Chairperson of and the Material Review Board.
Build Quality (QA, QE, QC) staffing (inclusive of contractors) to support commercial facility and full cGMP readiness (inclusive of regulator audit readiness).
Maintains and evolves the Quality Control Analytical and Microbiology labs and the plant environmental monitoring program.
Complete QA/QC and other applicable sections of US FDA, and Japanese PMDA and other regulatory submissions.
Other duties as assigned.