Quality Management System (QMS) Lead

Company Description

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.

Job Description

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: Independently prioritizes and executes a diverse portfolio of operational tasks—including simultaneous document releases, study training rollouts, and CAPA tracking—managing competing timelines across fast-moving clinical trials.
- Problem-Solving: Addresses operational and system-related bottlenecks, such as workflow stoppages, formatting discrepancies, or lagging compliance, applying standard quality procedures and exercise of sound judgment to resolve issues efficiently.
- Strategic Impact: Directly underpins inspection readiness and data integrity across clinical development by maintaining accurate training records, transparent CAPA trails, and audit-ready document archives that protect trial credibility.

Independence

- Autonomy: Operates under general supervision with clearly defined quality objectives, executing day-to-day eQMS user management and document control tasks with high initiative and minimal oversight.
- Decision-Making: Makes sound operational decisions regarding document formatting compliance, workflow progressions, and training profile assignments within established quality parameters, knowing when to resolve matters directly and when to escalate compliance risks.
- Leadership / Mentorship: Provides friendly, accessible technical support and system training to eQMS end-users, mentoring less experienced colleagues on GxP documentation practices and continuous inspection readiness.

Values & Behaviours

One Team

- Collaboration: Works seamlessly across clinical operations, regulatory affairs, biometrics, safety, and external CRO partners to streamline document workflows and maintain compliant training records.
- Inclusive Leadership: Actively listens to user feedback and system challenges, ensuring cross-functional partners feel supported and empowered to navigate quality processes.
- Mentorship / Support: Serves as a patient, encouraging guide for colleagues navigating eQMS workflows, simplifying system complexity to build collective quality capability.

Adventurous

- Innovation: Explores and champions modern digital features, automation opportunities, and efficient workflow configurations within the eQMS to enhance user experience and eliminate administrative friction.
- Risk-Taking: Proactively experiments with improved tracking tools, reporting dashboards, and communication formats to elevate compliance transparency across global teams.
- Change Leadership: Serves as an enthusiastic champion of system upgrades and procedural changes, helping team members embrace updated processes with confidence and clarity

Dedicated to our Mission

- Accountability: Demonstrates meticulous, obsessive attention to detail in document version control, record archiving, and CAPA verification, taking personal pride in audit-ready quality systems.
- Resilience: Maintains calm focus, precision, and organization when managing shifting clinical study priorities, tight document approval deadlines, or high-pressure inspection environments.
- Inspiration: Reinforces the vital connection between thorough GxP documentation, reliable trial data, and our shared commitment to delivering transformative therapies to patients.

Qualifications

- Demonstrated practical expertise in electronic Quality Management System (eQMS) administration and GxP document control within a pharmaceutical sponsor, biotech, or clinical CRO environment.
- Solid hands-on experience configuring and administering modern validated electronic systems (e.g., Veeva Vault QualityDocs/Training, TrackWise, MasterControl, or Dot Compliance).
- Strong working knowledge of Good Clinical Practice (ICH GCP E6), 21 CFR Part 11 (Electronic Records and Signatures), and foundational GxP documentation regulations.
- Proven track record coordinating and maintaining study training matrices, role-based curricula, and qualification records (CVs, job descriptions) to ensure audit readiness.
- Experience tracking and supporting the resolution of deviations, Quality Issues, and CAPA lifecycles, including verifiable evidence gathering and compliance metric reporting.
- Demonstrated capability providing operational and administrative support during regulatory agency inspections (e.g., FDA, MHRA, EMA) or internal/vendor audits.
- Exceptional attention to detail, strong organizational skills, and proficiency in MS Office tools (advanced Word document formatting, Excel data management, SharePoint) and electronic signature platforms (DocuSign Part 11).

Additional Information

- Pension (10% employer contribution)
- Private Medical Insurance (PMI) (including optical and dental cover)
- Health Cash Plan
- Group Life Assurance (4x basic salary)
- Group Income Protection
- Employee Assistance Program (EAP)
- Cycle to Work scheme
- Access to subsidised gym membership
- Time off (28 days annual leave in addition to bank holidays & the option to buy up to 5 additional days annually)
- Competitive reward including annual company bonus
- Employee recognition schemes
- Enhanced parental leave policies
- Flexible working environment
- State-of-the-art campus environment with on campus restaurant and Montessori nursery
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.