Quality Management System (QMS) Lead

THE ROLE (The Mission)  

Your mission is to serve as the operational backbone of R&D Qualityadministering 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 Bicycles validated electronic QMS (e.g. Veeva TrackWise Dot Compliance).
• Controlled Document Lifecycle Management: Manage the end-to-end lifecycleincluding drafting review workflows electronic signatures approval distribution periodic review and obsolescenceof 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Archiving & Records Management: Coordinate the compliant secure archiving and indexing of master controlled documents superseded revisions and historical quality records.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 metricssuch as SOP review cycles training compliance rates and CAPA resolution timelinesidentifying 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 tasksincluding simultaneous document releases study training rollouts and CAPA trackingmanaging 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.

Remote Work :

No

Employment Type :

Full-time