Senior Manager, Quality Assurance (Commercial Manufacture)

Senior Manager, Quality Assurance (Commercial Manufacture)
The Company:
Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this through the development of our first-in-class molecule, ensifentrine. Ensifentrine has the potential to provide relief for millions of patients suffering from a variety of respiratory conditions including chronic obstructive pulmonary disease (COPD), 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 Manager, Quality Assurance (Commercial Manufacture) to join our team, reporting to the Senior Director, Quality Assurance. In the role of Senior Manager, Quality Assurance (Commercial Manufacture), you will collaborate on the development, design, implementation, delivery, execution, and maintenance of the global Quality Assurance program, including audit and inspection management, issue management and program drug supply. Additionally, you will be responsible for assuring the compliance of projects and programs with company SOPs, policies and all applicable worldwide regulations and guidelines (e.g., EU Directives, US FDA, PMDA, ICH and National regulations).
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 build a company that will 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:

• With a primary focus on routine Commercial Manufacture, responsible for the assignment of batch disposition to ensure quality product is available.
• Responsible for the review and approval of labelling, batch records and associated documentation, including collaborative review of deviation investigations, out-of-specification/trend investigations, amongst other documentation.
• Responsible for commercial product complaints which includes liaising with CMO partners to ensure proper investigative efforts are taken and appropriate CA/PAs assigned.
• Responsible for ensuring any product complaints which are also adverse events are reconciled with pharmacovigilance.
• Management of change controls.
• Collaborating for the implementation of quality agreements with vendor partners to reduce ambiguity in organizational responsibilities and to increase partner cooperation.
• Collaborating for success of GMP vendor audit program, Act as a strategic and proactive internal expert, providing GMP quality oversight and industry compliance with a continuous improvement mindset; requires in-depth, working knowledge of corporate SOPs, GMPs, 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 (CA/PA).
• Interact and collaborate with Verona Pharma QA colleagues at other corporate locations to ensure consistency in application of Quality strategy and to promote standardization.
• Provide monthly quality and readiness dashboard ensuring there is a continuous improvement program to evolve and optimize procedures and/ or policies; identify and lead opportunities for improvements, efficiencies, and elimination of redundant activities.
• 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. Teams in attendance may be cross functional.
• Collaborate with QA colleagues at vendor location, as appropriate, to ensure direct Quality-to-Quality communication pathways and to communicate a clear understanding of Verona QA strategy across program(s). Interface with Senior Management to discuss quality and compliance issues, ensuring appropriate escalation, as required.
• Other duties as assigned.

Requirements:

• Bachelor's degree in a scientific discipline required.
• Minimum 7+ years of related experience in pharmaceutical, technical, Quality Assurance, or related area.
• Strong negotiation and influencing skills; demonstrated ability to work constructively and affectively 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 demeanor 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.
• Ability to influence and guide others; ability to work effectively and lead in teams.
• Strong Microsoft Office skills.
• Strong interpersonal skills.
• Effective organization and team orientation skills.
• Proficient in English Language.
• May be required 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.