Director Of Quality Assurance

List Biotherapeutics intends to be the market leader and premier CDMO to bring Live Biotherapeutics to market as we harness bacterial science to make the biggest impact possible and to help our customers create a healthier world. We are seeking an accomplished individual to serve as the Director of Quality.

This role is part of the project team for a new company implementing a greenfield site intended for phase 3 and commercial manufacturing of live biotherapeutic products. This role is critical to the development of a strategic plan and the Quality Function. The role requires broad management and leadership skills across several areas. This involves leading multiple job areas with the ability to influence others to develop the vision and implementation of the Quality Functions in a new biologic product area that has yet to be brought to market. Successful candidate will possess the ability to apply a strategic view to the business whilst having proven skills of developing, articulating, and gaining alignment across the organization on the necessary quality policies, processes, and procedures that support advancement of the company’s vision.

·Leadership

oSolid leadership skills and demonstrated ability to build a forward-thinking Quality Systems and Operations; remove barriers, develop people and technical. capabilities; build an environment which enables people to perform at their best

oDevelop the organizational strategies, which ensure the implementation and long term GMP compliance of the site, continuous improvements, and achievement of long-term goals.

oBuild a culture of continuous improvement and model lean leadership principles.

oHave a firm understanding of people practices including mentoring, and coaching, and apply these in order to shape the site culture with an end-to-end view.

oPartner with team members on project and strategic initiatives and decisions.

Job Duties/Responsibilities

·Collaborate with cross-functional internal and external teams to ensure that quality requirements are incorporated into the facility design and construction plans. Provide input on critical aspects such as facility layout, equipment selection, utilities, and HVAC systems to ensure compliance with regulatory and quality standards.

·Lead to build and implement quality systems and infrastructure in phased approach that oversee facility, equipment, utilities, documents and computerized systems.

·Drive the implementation of a comprehensive risk management program for the facility, including identification, assessment, and mitigation of risks associated with quality, safety, and compliance over the project phase. Collaborate with cross-functional teams to develop risk management plans and support risk-based decision-making processes.

·Develop and execute the regulatory inspection readiness program for approval of the new microbiome site for manufacture ofphase 3 and commercial products, as intended,by applicable health authorities.

·Develop or guide the strategy and direction ofCommissioning and Qualification for the new microbiome site, quality risk assessment, process performance qualification, etc.

·Establishes and implements policies and procedures related to quality, compliance and product development, tech transfer and process validation and ensure that the procedures are properly followed and adequate for their intended use.

·Drive a culture of continuous improvement by promoting quality awareness, fostering a proactive approach to problem-solving, and implementing Lean Six Sigma principles and methodologies. Identify opportunities for process optimization, efficiency enhancement, and cost reduction.

·Reporting to project lead, ensure close collaboration and suitable coordination of project activities across various stakeholders and parties.

Required Competencies

·Bachelor's degree in a relevant scientific discipline (such as Biology, Biochemistry, Pharmacy, or Chemistry) with 15+ years experience in the pharmaceutical, biotechnology, or GMP manufacturing industry

·Must have strong knowledge of and broad experience in product Quality Assurance and Quality Control activities.

·In-depth knowledge of regulatory requirements and industry guidelines for biological manufacturing, including GMP, GLP, and relevant international regulations

·Strong understanding of quality systems and quality management principles, as well as experience with the implementation and maintenance of QMS

·Excellent interpersonal, organizational and communication skills

·Demonstrated leadership and the ability to motivate others

·Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives

·Sound knowledge of a wide variety of biological, analytical, and instrumental disciplines

·Demonstrated leadership experience brining a biologics product to commercialization

·Extensive experience dealing with FDA in inspectional situations and response activities

·Working knowledge of manufacturing and design control principles and practices in the biopharma industry