Do you want to take a key leadership role in shaping the Quality Assurance foundation for a growing biotech expanding its clinical activities?
If you thrive in dynamic environments and are skilled at building scalable GxP quality systems, this is a unique opportunity to make a significant impact at Gubra.
We are establishing a dedicated GxP Quality Assurance function to support our expanding drug development activities across non-clinical, CMC and clinical programs. As our new Director of GxP QA, you will set the direction, build the framework, and ensure that Gubra is fully prepared for early clinical development and regulatory interactions.
This is a senior strategic role suited for an experienced QA leader with deep knowledge of GCP and a strong understanding of broader GxP requirements. You will join a biotech environment driven by scientific excellence, fast execution, and strong cross-functional collaboration.
Lead the development and scaling of a GxP Quality Management System
Your primary responsibility will be to design, build, and operate a scalable Quality Management System (QMS) that supports Gubra’s journey into clinical development. You will enable teams in Development to work within a robust, compliant, and practical QA framework.
Your main areas of responsibility include
- Building a fit-for-purpose GxP Quality Management System: Develop and maintain a scalable QMS, govern GxP policies and SOPs, act as system owner for electronic quality systems, and drive quality metrics, management reviews and continuous improvement. You will help shape a strong, pragmatic quality culture grounded in data integrity.
- Providing integrated GxP QA oversight across drug development: Lead GCP QA as Gubra enters clinical development, ensure coherent GxP governance across clinical, CMC and non-clinical programs, and drive inspection readiness in alignment with ICH E6(R3). Ensure QA oversight for all phases of clinical trials. Provide strategic QA guidance to Development leadership and cross-functional teams.
- Managing vendors and audit programs: Oversee risk-based auditing of CROs, clinical sites, and CMC partners. Manage Quality Agreements with internal stakeholders and ensure ongoing vendor performance monitoring.
- Strengthen quality systems, training and culture: Improve and oversee deviation, CAPA and change control processes with robust root-cause analysis, ensuring cross-functional alignment and reporting key quality metrics. Own the GxP training system for Development and promote strong data integrity and documentation practices.
Your background
You are an experienced QA leader who thrives in biotech settings where systems are evolving and impact is tangible. You balance compliance with operational reality and enjoy building fit-for-purpose solutions.
Your background includes
- 10+ years of GxP QA experience in biotech or pharmaceutical industry. BS or higher degree in life sciences.
- In-depth knowledge of global GCP regulations with a minimum of 5 years of experience in GCP QA leadership. Experience adapting QMS to regulatory changes (e.g., ICH E6(R3)) is highly desired.
- Strong working knowledge of GMP and GLP.
- Experience scaling a QMS in a growing biotech is highly desired.
- Experience with audits and QA oversight of third-party vendors, clinical sites and internal systems and processes, either hands-on or through collaboration with external auditors or consultants.
- Strong understanding of computerized system validation (CSV) and data integrity principles.
As a person you are
- Able to operate independently and confidently.
- A clear communicator able to influence senior stakeholders.
- Pragmatic and biotech-minded, balancing compliance with operational reality.
- Comfortable operating within a lean QA function in the initial phase.
Contact and application
Please apply using the Apply button. The application deadline is January 12, 2026.
If you have questions about the role, you are welcome to contact Anja Mosekjær Bengtsson, Senior Director at anb@gubra.dk. We look forward to receiving your application.
About Gubra
Gubra is an ambitious contract research organisation (CRO) and biotech company striving for excellence at all levels. We insist on doing things efficiently – and often differently - to reach the results we aim for. Our vision is to become leaders in the fight for a more sustainable and healthier world. We do that by facilitating the discovery of new medicine, and by acting and inspiring others to fight the ongoing climate and biodiversity crises.
Gubra’s activities are focused on the early stages of drug development and are organised in two highly synergistic business areas: CRO Services and Discovery & Partnerships (D&P). We generate our revenue by performing research for life science companies as well as by partnering projects from our discovery and development pipeline.
Our therapeutic focus is within metabolic and fibrotic diseases, and we specialize in in vivo pharmacology, ex vivo assays, drug profiling, histology, stereology and whole brain and organ imaging. In addition, we offer a full palette of advanced transcriptomics. Our ML/AI-driven peptide drug discovery platform streaMLine enables us to rapidly develop a peptide hit into a non-clinical candidate ready for development. Through a constant focus on high quality, scientific excellence, speed, and solid teamwork we have established ourselves as a highly professional and competent partner in the market.
People are our greatest asset, and our team consists of +290 employees. The mix of people from different cultures and educational backgrounds combined with our entrepreneurial mindset have greatly impacted our working environment, which is characterized by entrepreneurial drive, scientific curiosity, and teamwork – we join forces!
