Senior Director, Clinical Quality Assurance

About the position

Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Responsibilities

• Lead the implementation and execution of Rocket's Good Clinical Practice (GCP) Quality Management System, writing and approving documents as necessary to ensure the design and content is compliant with applicable regulations and industry best practice
• Determine the strategy for and lead the implementation and execution of inspection readiness plans and activities
• Develop and provide training sessions based on previous and current audit and inspection learnings
• Prepare clinical audit plans and conduct GCP audits of clinical sites and service providers, generating audit reports and communicating findings to relevant stakeholders in a manner that ensures corrective and preventative actions are systemic and durable
• Serve as a strong technical resource when called upon to resolve GCP or Pharmacovigilance (PV) issues based on knowledge of relevant SOPs, clinical trial material production history and local regulations
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulation. Identify root causes for recurrent issues, communicate lessons learned and provide expert advice/information to quality and clinical operations staff
• Support clinical vendor selection and qualification activities and develop periodic compliance/metric reports
• Work closely with existing CRO(s) to ensure sponsor-delegated responsibilities are being carried out in a compliant manner, including change management, deviation handling and pharmacovigilance processes
• Participate on clinical process improvement projects and initiatives, supporting corporate and quality goals and priorities, and interacting with a diverse range of groups within and outside the organization, including third-party service providers, Clinical Research, Legal, IT, Data Management, CMC, Regulatory Affairs, CRAs, Investigators, Study Nurses and other study site personnel
• Evaluate new regulations and guidance for necessary revisions to the clinical quality program and identify and communicate business and regulatory risks
• Give guidance and support to Clinical and other departments on data integrity and Good Documentation Practices
• Prepare training materials and deliver training as necessary
• Demonstrate and promotes Rocket Pharma values and behaviors

Requirements

• Master's Degree in Life Sciences field
• 15+ years of relevant clinical experience in pharma/biotech company
• Demonstrated ability to lead a team
• Direct clinical site audit experience required
• Knowledgeable in risk-based methodologies and their application
• Vendor oversight and management experience
• Well versed in ICH/US/EU clinical regulations and guidelines with a demonstrated track record of compliance success
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
• Detail orientation, with strong communication and organizational skills
• Demonstrated ability to solve problems

Nice-to-haves

• Preference given to candidates with experience in ex-vivo cell or gene therapy
• ASQ or similar certification preferred

Benefits

• Generous 401K match
• Stock options
• Excellent health benefits