3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique technology platforms for the
The Director/Assoc. Dir of Quality will direct all Quality System and Product Quality strategies and activities at 3DBio. The Director will design, implement and manage the company’s quality management system (QMS) in compliance with regulations and standards for Biologics and Medical Devices. The Director is responsible for planning and executing activities related to all aspects of Quality Assurance and Quality control including but not limited to Quality System and Product Quality Activities.
This individual will lead the build-out of the Quality function and its capabilities. S/he will Support the Dir Manufacturing in the build-out of a new manufacturing site that will support product development, Clinical manufacturing, and technical transfer. This individual will be implementing a QMS for Biologics and Devices and product releases for internally manufactured products as well as external CMOs.
S/he will lead the establishment of the quality Risk management plans that will govern the program management reviews working closely with the business stakeholders with the objective of ensuring transparency and operational delivery across all GXP functions.
This individual has responsibilities for Quality associated with CMC operations expanding from preclinical, clinical, manufacturing and distribution. The Director will be an individual who has demonstrated success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence.
Development and Ownership of the Quality Management System
- Ensure the QMS is capable and effective at all levels; achieve and maintain compliance to US and international standards at our Long Island City facility.
- Build the Quality Department infrastructure to ensure compliance to company, industry standards, and the applicable regulatory requirements.
- Design and implement a phase-appropriate QMS for Biologics and Medical Devices in an organization with both internal and outsourced manufacturing.
- Establish and actively direct quality management sub-systems to achieve continual compliance and consistency that include: Deviations, CAPA, Document Control, Process control, Supplier management, Training, Batch disposition, etc
- Conduct periodic reviews of the state of effectiveness of the Quality System with Executive Management.
Provide strategic quality/compliance guidance for GCP/GMP
- Build out of Quality Management Systems to support the development, manufacturing and clinical management and oversight.
- Oversee outsourced CMC activities at CMOs, CROs
- Build a risk management plan to support manufacturing and clinical activities
Build capabilities for support of internal facility manufacturing and disposition of starting materials, intermediates and Drug Products in support of Clinical Studies including Analytical testing.
- Responsible for establishment and oversight of the Quality Testing within a new facility
- Responsible for QA Oversight of facilities and utilities in the manufacturing facility
- Perform / oversee QA review of Master and Executed Batch Records. Accountable for ensuring the compliance and safety of products dispositioned for clinical use.
- Evaluation of Investigations/ OOS/ Change Controls
Establish Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight
- Audit planning (including Supplier audits), conduct, findings, responses, and corrective and preventative actions.
- Build auditing capabilities to support vendor qualifications
- Establish and maintain Quality Agreements
- Work with the business areas on vendor selection
- Work closely with Regulatory to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
- Responsible for real-time inspection readiness
Support the Regulatory strategy of filing and approval of IND, BLA, IDE, PMA
- Evaluate the Regulatory Strategy for compliance with internal source documents
- Draft, review and approve relevant sections of regulatory filings
Individual Development/ Training
- Responsible for talent recruitment and development and maintains a plan that provides for succession and continuity in the most critical positions
- Establish Goals that align with the department and corporate strategies/goals
- Fosters a culture of innovation, transparency, and accountability
- Develops a superior, high-performing team that meets increasing needs and requirements across the business and helps drive the overall organization forward
- Bachelor's degree in a scientific field (or equivalent degree) plus 15+ years of relevant work experience, or relevant comparable background, or Master's degree and 8-10 years of relevant work experience. Experience/knowledge of biologics and/or Medical Device and regulations. ASQ or RAPS certification is a plus
- Working knowledge of compliance best practices for cell-based products.
- Experience dealing directly with FDA and notified bodies and knowledge of appropriate FDA, ISO, and global regulations regarding quality systems.
- Comprehensive knowledge of US Quality System requirements and domestic and international GCP and GMP regulations
- Experience working with Contracted Organizations and management of a manufacturing site
- Aptitude to succeed in the culture of a fast-paced, publicly-traded, start-up biotechnology company.
This is a full-time position based in Long Island City, NY.