Senior Director, Global Quality

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Welcome to Disc Genics, 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 Disc Genics, 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 Disc Genics 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  and see how you can contribute to revolutionizing patient care through regenerative therapies.

Are you ready to make a global impact in the rapidly evolving world of regenerative medicine? Disc Genics is seeking a Senior Director, Global Quality to champion quality across our organization and shape the future of patient care.

• 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 Disc Genics values.
• Lead initiatives that enhance organizational effectiveness and employee engagement.

• Serve as Management Representative for Disc Genics, 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.

• Experience with 21 CFR 211 and/or 21 CFR 820 and/or 21 CFR 1271
• Familiarity and experience…