Vice President, Quality Assurance

Vice President, 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 Vice President, Quality Assurance to join our team, reporting to our Senior Vice President of Regulatory Affairs. In the role of Vice President, Quality Assurance, you will be responsible for the strategic development and operational management of Verona’s Quality Assurance (QA) function and Quality Management System (QMS), and accountable for ensuring consistent and harmonized execution of systems and processes.

Remote work 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 provide leadership for the QA function at Verona, encompassing all GxP areas (GMP, GCP, etc.).

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:
 

• Provide leadership for the QA function at Verona, encompassing all GxP areas (GMP, GCP, etc.).
• Responsible for oversight, management, and development of QA function, including management of QA staff.
• Accountable for implementation and maintenance of QMS strategy, framework, methodology, infrastructure, and procedures to ensure compliance with regulations.
• Assess functional and organizational competencies, address gaps, plan and implement solutions.
• Assure hiring decisions and quality of hires address QA strategic and functional needs of the company; advocates for resources when needed.
• Mentor and develop competencies of QA team members.
• Oversee development and implementation of an audit and compliance program; may conduct audit and qualification activities for GxP vendors, investigator sites, and internal departments.
• Support and partner with matrix teams (e.g., Clinical Operations, CMC, etc.) to support continuous improvement efforts, including revision to or development of new Standard Operating Procedures (SOPs).
• May participate on project teams to ensure and/or provide GxP compliance support, including review of Quality Events and CAPAs.
• Identify, evaluate, and provide risk assessment of quality issues; escalating as needed.
• Support inspection readiness activities and participate in regulatory inspections.
• Evaluate and implement GxP computer systems, as needed to support business priorities, and ensure appropriate computer systems validation activities are conducted.
• Serves as budget owner for QA function.
• Other duties as assigned.

Requirements:
 

• Bachelor’s degree in Life Sciences or related field required.
• 17+ years of progressive compliance experience in quality functions in pharmaceutical/biotech industry with extensive experience across multiple GxP areas (GMP, GCP, etc.).
• Proven track record in establishing a quality organization and managing GMP Quality staff with successful track record of building, coaching, and mentoring a high-performing team.
• Hands-on leader, able to provide solution minded approach and flexibility to emerging challenges.
• Advanced knowledge of GxP regulations, including USA (FDA), EU (EMA), UK (MHRA), ICH Guidelines and working knowledge of RoW regulations.
• Previous experience preparing for and leading Health Authority/Regulatory inspections.
• Versed in phase appropriate practices of clinical vs. commercial manufacturing requirements.
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Adept in building working relationship between QA and other operating functions.
• Strong written and oral communication skills; ability to present to senior management teams, collaborators, and partners.
• Able to appropriately balance priorities and multitask amidst competing priorities.
• Works effectively and cooperatively with others; establishes & maintains good working relationships.
• Able to develop solutions to complex, ambiguous problems, including outside own area of expertise and typically as part of a team.
• Strong strategic, critical thinking skills with ability to influence leadership across R&D, Legal, and IT.
• Excellent verbal, written, and presentation skills.
• Ability and willingness to travel up to 25% to support project and/or company needs.
• May be required to travel by air/train/car for meetings, conferences, audits, and regulatory inspections, as needed/up to 25%.

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.