Remote Vice President, Quality Assurance

Summary

Join Verona Pharma as Vice President, Quality Assurance to lead the strategic development and operational management of the company's Quality Assurance function and Quality Management System.

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

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