Background

Trialspark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients.

Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.

About the role

Reporting to the CEO, the Head of Quality will pursue a strategic and tactical mandate leading the development and execution of a worldclass and innovative QA engine to support a mission of streamlining clinical trials. You will be tasked with driving innovation in the quality function and partnering cross functionally to drive change across the broader organization 

Our ideal candidate should possess deep strategic and tactical GCP-related quality experience in areas including clinical operations, audit readiness and training. The Head of Quality will lead an approach that anticipates and addresses the needs of clients and internal operations teams. Critically, this executive will possess a record of leadership and demonstrated success scaling teams and systems in high-growth, regulated environments. The Head of Quality will respond to changing regulations and ensure appropriate regulatory guidelines, while pushing the boundaries of innovation. 

Responsibilities 

• Develop strategic and tactical approaches to facilitate the Company’s efforts to redefine clinical trial processes, while supporting operations from a regulatory compliance perspective. 
• Lead the development and build of a world class quality engine and management system to support TrialSpark’s broad network of clinical trial sites and processes. 
• Determine quality requirements in accordance with current regulations and business mission, and implement through functional groups. 
• Provide guidance, support, training, and key input to development groups regarding the interpretation of regulations, guidelines, corporate standards, and policies. 
• Develop and implement comprehensive compliance training across the organization. 
• Establish a versatile learning platform that trains employees on SOP’s, ensures adherence, and functionally allows for compliance tracking. Create a mechanism through which TrialSpark will safely share SOPs with clients. 
• Structure an SOP review cycle to drive and ensure continual quality improvement. 
• Identify areas of exposure; develop and execute mitigating strategies while promoting company wide quality improvement efforts. 
• Work closely with operational groups to prepare and lead audit readiness initiatives across the organization. 
• Provide guidance and direction to ensure vendor qualifications and successful outcome of client audits and regulatory inspections. 
• Conduct internal and external quality audits and review of corrective action plans. 
• Liaise and establish relationships with the FDA and other relevant regulatory bodies (EMEA, MHRA, etc.); communicate regulatory directives to the broader organization. 
• Anticipate and monitor the impact of changes in guidelines and regulations. 
• Identify and facilitate innovative solutions that address barriers and challenges to executing quality management initiatives. 
• Implement a system to track and manage CAPA (Corrective and Preventive Action). 
• Track and report KPI metrics to senior management. 

Key Requirements 

• Bachelor or higher level degree, ideally with a scientific foundation (e.g. Biology, Chemistry). 
• Established background in regulatory compliance with at least 8-10 years of experience working in a biopharmaceutical industry setting while holding GCP, Quality Assurance oriented roles. 
• Extensive knowledge of pharmaceutical research and development processes in regulated environments. 
• Deep understanding of ICH GCP standards as applied to the design, conduct, performance, monitoring, auditing, analysis and reporting of clinical trials. 
• Demonstrated ability to lead and manage quality initiatives across multiple diverse settings. 
• Record of building and scaling quality teams and quality management systems in high growth environments. 
• Past exposure and engagement leading interactions with the FDA and other relevant regulatory authorities. 
• An adaptable and nimble approach; record of working in fast paced, data-driven and continually evolving organizational settings. 
• An entrepreneurial and innovative mindset focused on driving change and challenging conventional norms. 
• Ability to rank, order and prioritize work. 
• A communicative, collaborative leader with a “Can-Do” approach to working with clients and operational teams. 

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.