Senior Director, Quality Assurance

2 months ago

Raleigh, United States Verona Pharma Full time
Job DescriptionJob DescriptionSenior Director, Quality Assurance

The Company:

Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. Our first product is now approved by the US FDA for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults and we continue to develop our respiratory pipeline. We aim to provide relief for millions of patients suffering from a variety of respiratory conditions including cystic fibrosis (CF), non-CF bronchiectasis and asthma. Our focus is driven by our desire to ensure that innovative and differentiated molecules can reach these patients.

The experience of the Verona team, and its highly effective leadership allows us to challenge the status quo in drug development and commercialization. Verona provides a professional, diverse, and inclusive working environment where our employees thrive. We are driven to succeed by our desire to help those dealing with the chronic progressive nature of respiratory diseases. We offer you the opportunity to help create a new future for those people living with respiratory diseases.

The Opportunity:

Verona Pharma is currently recruiting a Senior Director, Quality Assurance to join our team, reporting to our Vice President, Quality Assurance. In the role of Senior Director, Quality Assurance, you will oversee the development, design, implementation, delivery, execution, and maintenance of the global Quality Assurance strategy for an assigned GxP discipline, including audit and inspection management, issue management, drug supply, and oversight of the Quality Management System (QMS).  Additionally, you will be responsible for assuring the compliance of projects, products, and programs with company SOPs, Policies and all applicable worldwide regulations and guidelines (e.g., EU Directives, US FDA, PMDA, ICH and National regulations).

Remote working and flexibility are important parts of our culture at Verona. However, we are looking for candidates based in the Raleigh/Durham/Chapel Hill area as you will periodically be required to go into the Raleigh office for key meetings, training, and other activities as needed.

To be successful in this role, you must have demonstrated expertise in implementing successful process and continuous improvement efforts, yielding increased effectiveness and efficiency.

We know our employees are our most valuable asset, and our culture conveys that.  Trust, accountability, and efficiency are core values that drive our working environment.  We have a unique opportunity to bring a first-in-class medication to chronic respiratory disease patients with significant unmet needs.  We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

Responsibilities:
 
  • Act as a strategic and proactive internal consultant, providing input and guidance to situations that arise; requires in-depth, working knowledge of corporate SOPs, GxPs and applicable regulations and guidelines.
  • Generate and/or review key quality documents, including, but not limited to, Standard Operating Procedures (SOPs), Policies, Protocols, 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.  Provide support for new employee training, ensuring assignment and documentation of SOP and policy training.
  • 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.
  • Other duties as assigned.
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%.
An Equal Opportunity Employer:

Verona Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Verona Pharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
 

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