Senior Director, Quality

Job Summary

The Senior Director of Quality functions as the Management Representative and Head of Quality at DiscGenics, overseeing Quality Assurance, Quality Control, and Microbiology. Reporting directly to the CEO, this role supports DiscGenics' clinical trial initiatives, cGMP commercial manufacturing operations, and preparations for regulatory filings in advance of commercial approval in defined markets.

Essential Duties And 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.
• 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.
• 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.

Job 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
• 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
• Able to report to work unimpaired

Education And Experience

• 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.
• 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).