Senior Manager, GCP Quality Assurance

Job Description
Senior Manager, 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 team tasked with product development, 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. 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 development
Develop and maintain quality dashboards/ metrics
Anticipate, 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.
Support applicable change management pertaining to new and/or evolving global regulations, and anticipate any changes that may impact the development strategies for programs
Support 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 requirements
Participate in the planning, conduct, management, review, documentation, communication and follow up of internal and external quality audits, vendor qualification and assessments
Contribute to the development and delivery of Quality training modules for internal company employees enabling a culture of quality throughout company
Support preparation for, and coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
Support 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.
Assist development team business partners with development and documentation of CAPAs and effectiveness checks, as applicable.
Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.