Quality Management System; QMS) Lead

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® Radio conjugates (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

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, Track Wise, 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…