Tubulis GmbH

QA Engineer

• Create and maintain global GCP audit programs in collaboration with the Director QA-GCP.
• Manage the vendor qualification program of assigned vendors.
• Manage (planning, execution, and delivery) and/or oversee audit activities in the GCP area for all phases of clinical studies, suppliers, systems, and documents to assess compliance with Tubulis SOPs and applicable regulations and guidelines (e.g. ICH, CTR, US FDA, and National regulations), identifying compliance issues, communicating results to and educating auditees, project teams, and management.
• Manage audit activities (planning, execution, and delivery) for GLP vendors and review and approve GLP quality documentation provided by vendor.
• As subject matter expert provide GxP expertise (interpretation and guidance), in collaboration with relevant internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activities.
• Represent QA in internal meetings, e.g. in Tubulis Trial Team meetings, as assigned.
• Act as QA counterpart to GCP/GLP vendors to address and resolve any quality issues.
• Support regulatory inspections (preparation, hosting, follow-up), as requested.
• Support Director QA GCP in development and maintenance of quality management systems (QMS) in the area of GCP/GLP.

Manager QA GCP/GLP

Operations

🌐
Worldwide
Post a Job
Affiliates
❌ Jobs You've Hidden
⭐️ Saved Jobs
✅ Applied Jobs
Account
This job opening is no longer available.
Similar Jobs
Medical Operations - DACH

🕒 June 29, 2025

Tandem Health

201 - 500

Website
LinkedIn
All Job Openings

Join Tandem Health to help clinicians reclaim time and focus on patient care through innovative technology.

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

🗣️🇩🇪 German Required

Operations Manager - Produktion

🕒 May 27, 2025

AUTO1 Group

5001 - 10000

👥 B2C

🏪 Marketplace

🚗 Transport

Website
LinkedIn
All Job Openings

Oversee enhancements of production processes for online used vehicle purchases in Germany.

🇩🇪 Germany – Remote

💰 Convertible Note on 2020-07

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

🗣️🇩🇪 German Required

Senior Technical Operations Specialist

🕒 May 5, 2025

Distribusion Technologies

51 - 200

🚗 Transport

☁️ SaaS

Website
LinkedIn
All Job Openings

Join Distribusion to enhance operational efficiency for a leading ground transportation marketplace.

🇩🇪 Germany – Remote

💰 Series B on 2022-06

⏰ Full Time

🟠 Senior

⚙️ Operations

Senior Technical Operations Specialist

🕒 May 5, 2025

Distribusion Technologies

51 - 200

🚗 Transport

☁️ SaaS

Website
LinkedIn
All Job Openings

🇩🇪 Germany – Remote

💰 Series B on 2022-06

⏰ Full Time

🟠 Senior

⚙️ Operations

Search More Operations Jobs
🌐
Worldwide
Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com
Search
Search Jobs by country
Search jobs by city
Search jobs by job title
Search entry-level jobs
Search junior-level jobs
Search senior-level jobs
Search jobs by tech stack
Search jobs by contract type
Search remote internships
Search remote part-time jobs
Remote jobs Anywhere in the World
Companies Hiring Anywhere in the World
Companies Hiring Sales People Anywhere in the World
Companies Hiring Software Engineers Anywhere in the World
Resources
Advice
Tips for finding remote jobs
Interview questions and answers
Resume examples
Cover letter examples
Post a job
Affiliates
Privacy policy
Terms of service
Job board SEO course
AI Apply Copilot
OpenClaw job finder
Jobs by Country
Remote jobs anywhere in the world (Worldwide remote jobs)
Remote jobs United States
Remote jobs Australia
Remote jobs Brazil
Remote jobs Canada
Remote jobs France
Remote jobs Ireland
Remote jobs Germany
Remote jobs Netherlands
Remote jobs Spain
Remote jobs UK
Popular Jobs
Remote data analyst jobs
Remote customer support jobs
Remote executive assistant jobs
Remote marketing jobs
Remote product designer jobs
Remote product manager jobs
Remote project manager jobs
Remote recruiter jobs
Remote sales jobs
Remote software engineer jobs
Jobs by Type
Remote full-time jobs
Remote part-time jobs
Remote contract jobs
Remote internship jobs
Remote entry-level jobs
Remote jobs with no experience required
Remote junior jobs (1-3 years of experience)
Digital nomad jobs
Remote jobs with no degree required
Freelance remote jobs
Temporary remote jobs
Remote jobs hiring now
Stay at home mom jobs

Associate Director, Operational Excellence

Manager

• Help build Tubulis’ enterprise strategy and insights capability.
• Turn competitive intelligence, market context, and external signals into decision-ready frameworks and recommendations.
• Function as an internal strategy and analytics partner to Clinical Development, R&D, and Commercial.
• Translate external intelligence into clear implications, options, and recommendations.
• Build frameworks and capabilities that guide portfolio choices, resource allocation, and business development strategy.
• Evaluate potential oncology assets using data-driven methodologies.
• Conduct holistic asset assessments evaluating strategic fit with Tubulis platforms, operational feasibility, commercial potential, competitive differentiation, and regulatory pathway.
• Build comprehensive business cases for licensing opportunities including market sizing, epidemiology-based patient population forecasts, and revenue projections.
• Monitor and assess the oncology ADC competitive landscape.
• Conduct deep-dive competitive analyses and identify emerging trends in ADC technologies.
• Generate regular competitive intelligence reports and landscape updates for BD leadership and executives.
• Provide competitive context and market intelligence to inform Clinical Development trial design and indication prioritization.
• Develop repeatable executive-ready outputs used across Clinical Development, BD, and Commercial Functions.

Senior Manager, Business Insights & Strategy

Data Scientist

• Lead clinical data management activities from study initiation through database lock.
• Develop, review and maintain core data management documents, including Data Management Plans, CRFs, Edit Check Specification, Data Transfer Plans, Data Review Guidelines.
• Drill down into data irregularities and resolve issues with data miscoding, missingness, or analysis errors.
• Collaborate with internal teams and external vendors to define EDC specifications, ensure accurate CRF build, execute data cleaning activities (e.g. query resolution, SAE reconciliation, coding review), and manage the reconciliation and integration of external data sources (e.g., central labs, imaging, ePRO) into the study database.
• Facilitate cross-functional data review meetings and ensure timely resolution of data discrepancies.
• Oversee database lock planning and execution while managing CROs and external vendors to ensure all data deliverables meet project standards, timelines, and requirements for statistical analysis and regulatory submission.
• Track milestones and deliverables, and manage escalation and resolution of issues.
• Contribute to continuous improvement activities, including SOP development and implementation of best practices in clinical data management.

Manager QA GCP/GLP

Associate Director, Operational Excellence

Senior Manager, Business Insights & Strategy

Clinical Data Manager – Senior