Quality Management System (QMS) Lead

About Bicycle Therapeutics   Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle® molecules attractive candidates for drug development. The company is evaluating nuzafatide pevedotin (formerly BT5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of Bicycle® Radioconjugates (BRCs) and imaging agents; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle® technology to develop therapies to treat diseases in a range of therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts, USA. For more information, visit bicycletherapeutics.com  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.  THE ROLE (The Mission)   Your mission is to serve as the operational backbone of R&D Quality—administering, optimizing, and maintaining our electronic Quality Management System (eQMS) to ensure seamless GxP document control, comprehensive training compliance, robust CAPA management, and continuous inspection readiness across our clinical development programs. The Quality Management System (QMS) manager is responsible for the day-to-day operational administration, maintenance, and compliance oversight of the electronic Quality Management System (eQMS) for R&D. The successful candidate will play a critical role in supporting the R&D Quality Assurance and Development Functional Area teams. This role will oversee GCP/GLP/GPV document control, manage GCP/GLP/GPV study training matrices, facilitate deviation/CAPA tracking, follow up on CAPAs through to completion, collect CAPA evidence of completion, and administer quality records to ensure continuous inspection readiness. YOUR RESPONSIBILITIES    1. eQMS Administration & GxP Document Lifecycle Control System Administration & Ownership: Act as the primary administrator, subject matter expert, and "go-to" operational contact for Bicycle’s validated electronic QMS (e.g., Veeva, TrackWise, Dot Compliance). Controlled Document Lifecycle Management: Manage the end-to-end lifecycle—including drafting, review workflows, electronic signatures, approval, distribution, periodic review, and obsolescence—of GxP Standard Operating Procedures (SOPs), quality policies, work instructions, and clinical study templates in close partnership with functional authors. Document Integrity & Compliance: Maintain strict formatting, version control, and template adherence in compliance with internal style guides, regulatory documentation standards, and 21 CFR Part 11 requirements. Secure Archiving & Records Management: Coordinate the compliant, secure archiving and indexing of master controlled documents, superseded revisions, and historical quality records. Data Extraction & Process Reporting: Generate, extract, and analyze controlled document metrics to identify review bottlenecks, upcoming review milestones, and procedural gaps across R&D. 2. Training Management & Compliance Oversight Curriculum & Matrix Administration: Configure, deploy, and maintain study-specific and role-based GxP training curricula and matrices within the eQMS across clinical, non-clinical, and pharmacovigilance teams. Onboarding & Offboarding Workflows: Partner cross-functionally with Functional Area Leads, HR, and IT to ensure timely assignment, modification, and deactivation of training profiles for new hires, role transitions, and external contractors. Compliance Tracking & Escalation: Actively track training completion rates across global teams, follow up directly with users, provide automated compliance dashboards to line managers, and proactively flag overdue assignments to functional leadership. Personnel Qualification Records: Oversee the collection, review workflows, routine updates, and compliant archival of essential qualification documents, including CVs, Job Descriptions (JDs), and GxP training certificates. 3. Deviation, CAPA, and Quality Event Support Quality Event Logging & Workflow Support: Log, monitor, and facilitate the timely progress of clinical deviations, Quality Issues (QIs), and potential Serious Breaches through their defined eQMS workflows. CAPA Progression & Evidence Gathering: Track implementation milestones for Corrective and Preventive Actions (CAPAs), driving accountability with action owners and collecting verifiable evidence of completion prior to closure. Quality Trend & KPI Analysis: Extract, analyze, and compile quality performance data to populate periodic QA metrics and executive dashboards, helping uncover systemic process trends, repeat issues, or targeted training needs. 4. Audit & Inspection Readiness Audit Workflow Logistics: Support the administrative workflows for vendor assessments, internal audits, and clinical investigator site audits, tracking audit reports, observations, and audit responses through to closure. Inspection Room Operations: Provide pivotal administrative coordination and back-room support during sponsor regulatory authority inspections (e.g., FDA, MHRA, EMA) and partner audits. Rapid Record Retrieval: Rapidly locate, verify, and deliver essential clinical trial records, training histories, CVs, and system qualification logs requested by regulatory inspectors or auditors.   WHO ARE YOU: SKILLS & COMPETENCIES Knowledge Core Expertise: Applies solid technical understanding of validated eQMS platforms (e.g., Veeva Vault, TrackWise, MasterControl), electronic document management principles, and GxP regulatory requirements (ICH GCP E6, GLP, GPV, and 21 CFR Part 11) to administer day-to-day R&D quality systems independently. Data / Insight: Accurately extracts, aggregates, and interprets eQMS metrics—such as SOP review cycles, training compliance rates, and CAPA resolution timelines—identifying meaningful patterns and presenting actionable findings to R&D teams. Influence & Collaboration: Communicates clearly and persuasively across global study teams, functional area leads, and external vendors/CROs, adapting style to explain compliance workflows, resolve user issues, and promote quality best practices. Job Complexity Task / Project Delivery: Independen