Senior Director, Quality

Senior Director Of Quality

The Senior Director of Quality functions as the Management Representative and Head of Quality functions at DiscGenics (that includes Quality Assurance, Quality Control, and Microbiology) reporting directly to the CEO. Responsible for facilitating Management Review and the implementation of and maintaining a compliant Quality Management System (QMS) to support DiscGenics clinical trial initiatives, cGMP commercial manufacturing operations, and preparations for regulatory filings in advance of commercial approval in defined markets.

The Senior Director, Quality documents, monitors, and assures compliance to the Quality Management System with applicable government jurisdiction regulations. Responsible for building, managing, and mentoring a team of quality professionals that will train the organization on applicable regulatory requirements and ensure that the organization maintains compliance with applicable regulations.

This individual fulfills the Quality Policy by implementing Quality Objectives that are aimed at improving the Quality Management System. Delivers collaborative and positive leadership to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.

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.
• 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.

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
• 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

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).

Working Conditions:

Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.

Must be able to lift and carry up to 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.