Associate Director, Quality provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the Development Quality team, the position serves as a Quality and compliance business partner, engaging with multiple collaborators. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally, leading process improvement initiatives across the R&D organization. The position will be a member of the Development Quality group, reporting to the Head of Development Quality.Collaborate with global program teams to ensure protocol, procedural, GCP / regulatory compliance and inspection readiness throughout all stages of product developmentDevelop and maintain key quality indicators, metrics and critical to quality factors.  Review performance and establish thresholds around performance indicators and associated dashboard capabilityAnticipate, identify, communicate, and manage quality issues to resolution, including escalation to key stakeholders across the business.Contribute during internal cross-functional meetings to review and document oversight of company Quality initiatives and drive progress.Support applicable change management pertaining to new and/or evolving global regulations, and anticipate any changes that may impact the development strategies for programsSupport the review of key clinical trial documents (INDs, manuals, study plans, etc.) for compliance with existing policies and procedures, ICH GCP and applicable global regulatory requirementsLead preparation for, and coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspectionsSupport vendor selection/qualification activities (including but not limited to vendor audits and maintenance of preferred vendor list)Provide expert quality consultation to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable regulations. Identify and partner with key collaborator functions and business partners as appropriate.Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
