Senior Manager, GCP Quality Assurance

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.  
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together. 

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.

Qualifications

• The position requires a Batcheler’s degree in a science or healthcare field
• Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GCP quality/compliance role
• Knowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS)
• Knowledge of GLP /GCLP preferred
• Strong familiarity with eTMF requirements
• Experience conducting audits, reviewing audit reports and following up on CAPAs
• Experience leading quality event investigations/ root cause analysis
• A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing
• Highly collaborative, strong relationship building skills with high level of integrity.
• Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions
• Demonstrated ability to work proactively using solid communication and influencing skills to effectively