Associate Director

Location: Remote (Northeast preferred)

Position summary:

The primary responsibility of the Associate Director of Clinical Quality Assurance and Compliance will be to develop and lead all quality assurance and compliance activities for the clinical development organization at Invivyd. The individual will be accountable and responsible for driving Clinical Quality initiatives to completion in conjunction with Invivyd’s Regulatory and Clinical departments and external vendors. This position will also be responsible for coordinating, controlling, and continuously improving the internal quality assurance processes, primarily related to clinical development and related activities and systems. The Associate Director will coordinate audits to support GCP, GLP, GVP, and other regulated activities and lead strategy and activities in support of health authority inspections. The individual will ensure compliance of clinical trials and development activities to global regulatory standards including US FDA, ICH standards, and other international regulatory agencies. They will also be responsible for clinical inspection readiness activities for Invivyd’s development programs.

Responsibilities:

• Build the Clinical Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and other compliance-related activities
  • Participate on cross-functional team meetings as the Clinical Quality Assurance Subject Matter Expert (SME)
  • Create, implement, and maintain efficient, phase-appropriate, and compliant GCP, GLP, and GVP systems and policies/procedures
• Partner with other stakeholders across the organization to develop and maintain cross-functional SOPs, policies, procedures, and systems/activities consistent with corporate objectives
  • Stakeholders/partnerships include but are not limited to Clinical Operations, Pharmacovigilance, Regulatory, IT, CMC Quality Assurance, HR, Nonclinical Development
• Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management
  • Proactively identify potential quality issues/discrepancies and work with Management to effectively resolve in a compliant and timely manner
• Provide Clinical Quality Support for Clinical Vendor/CRO oversight:
  • Represent Invivyd Clinical Quality on Sponsor/CRO/Site project calls and provide updates to Management
  • Provide Clinical Quality support for critical quality issues, protocol deviations, investigations, root causes, and CAPAs
• Develop a risk-based audit program to conduct effective audits of internal processes, investigator sites, and vendors that support development activities
  • Establish clinical quality procedures and tools in support of audit and compliance activities
  • Collaborate with key stakeholders in development and implementation of internal and external GCP audit plans
• Assist in the development, implementation, and maintenance of training and compliance programs:
  • Directly responsible for GCP, GLP, and GVP training and conduct of associated training sessions as required
  • Partner with stakeholders on maintenance and implementation of other training across the organization (i.e., CMC Quality Assurance, IT, HR, Finance, Corporate Compliance, Medical Affairs) to ensure full compliance
• Proactively provide key stakeholders with intelligence on changes and updates to ICH and GCP regulations and assess impact on Invivyd systems and practices
• Lead strategy and activities in support of GCP, GLP, and GVP health authority inspections
• Review regulatory clinical and nonclinical documents such as protocols, clinical study reports, IBs, ICFs, etc. and check for consistency and compliance with relevant regulations, standards, and best practices

Competencies:

• Excellent written and oral communication and organizational skills
  • Ability to communicate complex information in a virtual environment
  • Ability to effectively multi-task and prioritize
• Ability to work in a cross-functional team collaboratively and independently
• Ability to flexibly adapt to changing business needs and meet timelines
• Ability to proactively identify and determine impact of issues on subjects, study conduct, clinical program development, and company needs based on stage of development and risk profile
• Strong attention to detail and good problem-solving skills
  • Proactive, resourceful, self-starter and team player with a strong result orientation

Requirements:

• A bachelor’s degree in a scientific discipline or biotechnology field
• A minimum of 6 years relevant GCP experience in pharma/biotech company, working within quality systems and regulated GCP/ICH environments
• Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory agency inspections
• Experience managing internal and external audits
• Strong understanding of GCPs, FDA, and ICH regulatory standards/guidance documents
• Extensive knowledge of risk-based quality systems approaches, with a focus on ICH E6 R2 GCP principles
• Experience using Veeva Quality Vault
• Ideally will also have experience in facilitating/participating in remote audits and quality activities; able to travel to Clinical sites/vendors as required; Travel Requirement expected to be up to 25%.