Verona Pharma is hiring a
Senior Director Quality Assurance, Remote - United States

Summary

The job is for a Senior Director of Quality Assurance at Verona Pharma, a company focused on improving health and quality of life for people affected by chronic respiratory diseases. The role involves overseeing the development and implementation of the global Quality Assurance strategy, ensuring compliance with company SOPs, Policies, and regulations, and collaborating with other teams to improve procedures and optimize policies.

Requirements

• Bachelor’s degree in a scientific discipline required
• Minimum 13 years of related experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience (or equivalent combination of education, training and experience)
• Strong influencing and interpersonal skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers
• Demonstrated analytical skills and strong attention to detail
• Strong knowledge of the principles for a GxP Quality Management System, FDA Regulations, EU Directives and Regulations, UK Statutory Instruments, PV requirements, ICH Guidelines and other relevant laws, regulations and guidance
• Excellent problem solving, risk analysis and negotiation skills
• Highly professional demeanour to effectively interact with senior internal leaders and external stakeholders
• Excellent communication and presentation skills; ability to speak and write clearly, and to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience
• Ability to be flexible regarding schedule and work projects
• Demonstrated experience designing and implementing an effective Quality Management System in a GxP setting
• Strong Microsoft Office skills
• Ability to travel by air/train/car for meetings, conferences, audits, and regulatory inspections, as needed, up to 50%

Responsibilities

• Act as a strategic and proactive internal consultant, providing input and guidance to situations that arise
• Generate and/or review key quality documents, including SOPs, Policies, Reports, Specifications, Quality Investigations and Corrective Actions and Preventative Actions (CAPA)
• Interact and collaborate with all other Verona Pharma QA colleagues to ensure consistency in application of Quality strategy and to promote standardization
• Ensure there is a continuous improvement program to evolve and optimize procedures and/or policies; identify opportunities for improvements, efficiencies, and elimination of redundant activities
• Develop and execute QA strategy, ensuring implementation and completion of audit program spanning investigator sites, vendors, processes, systems, regulatory submissions and associated clinical trial documents (including pre-clinical)
• Lead Quality interactions with Contract Development/Manufacturing Organizations (CDMOs), Clinical Research Organizations (CROs) and other vendors supplying GxP services, including the development Quality/Technical Agreements, as applicable
• Collaborate with interdisciplinary teams to ensure and appropriate link between preventative actions and the management of risk. Participate in or lead teams for special projects as assigned, including quarterly Quality Meeting, to include cross-functional team members where appropriate
• Lead and support inspection preparation (i.e., inspection readiness) and inspection strategy, as required. Undertake other essential and critical operational duties in line with department need, e.g., host audits and/ or regulatory inspections, and oversee preparations of any resulting Corrective and Preventative Action plans and effectiveness checks
• Responsible for ensuring internal stakeholders have a clear understanding of QA strategy, and that services are executed and delivered within budget

Benefits

Generous Paid Time Off