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DiscGenics · 1 week ago

Senior Director, Global Quality

Salt Lake City, UT

Full-time

Onsite

Director/Executive

8+ years exp

DiscGenics is a pioneering biopharmaceutical company focused on regenerative cell-based therapies for degenerative spine diseases. They are seeking a Senior Director, Global Quality to oversee Quality Assurance, Quality Control, and Microbiology functions while driving the implementation of a globally compliant Quality Management System.

BiotechnologyHealth CareLife ScienceTherapeutics

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

Qualification

Quality Management SystemCGMP complianceRegulatory submissionsInternal auditsTeam leadershipTechnical writingAttention to detailCommunication skillsCollaborationProblem-solving

Required

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

Considerable experience with successful eQMS and/or other Quality information system RFP process, contract negotiations, implementation, and roll out

Preferred

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)