Advanced QA Professional – QMS
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Bohumil • 🇨🇿 Czech
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Vault
About the role
- Lead implementation and maintenance of assigned QMS processes (change control, deviations, CAPA, QRM), acting as local process owner and Veeva Vault superuser.
- Ensure ongoing compliance with corporate QMS and Czech regulatory requirements by monitoring obligations and driving corrective actions.
- Design, deliver and manage QMS training programs to ensure personnel competency and timely completion of required training.
- Support audit and inspection readiness, participate in internal audits and regulatory inspections, and coordinate quality management reviews.
- Develop and execute quality assurance strategies and KPIs to monitor, measure and continuously improve QMS performance.
- Perform risk assessments across the value chain (production, QC, storage, distribution), provide mitigation recommendations and ensure implementation.
- Represent QA in cross-organizational process groups, provide expert advice on complex quality issues, and drive change and process optimization with high independence.
Requirements
- Bachelor’s or master’s degree in pharmacy, Chemistry, Biotechnology or a related field.
- Minimum 3 years in pharmaceutical quality assurance (or related field) with solid knowledge of GMP and regulatory standards.
- Proven ability to manage and improve QMS processes, implement quality assurance strategies, and act as superuser for systems like Veeva Vault.
- Strong analytical thinking and risk assessment skills to identify, evaluate and mitigate risks to patients and products.
- Effective communicator with experience delivering training and presenting quality recommendations to cross-functional stakeholders in Czech and English.
- Able to handle complex tasks, make independent decisions, and drive problem resolution with limited predefined procedures.
- Team player who works across functions, adapts to changing regulatory and operational demands, and contributes to continuous improvement initiatives.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
QMS processeschange controldeviationsCAPAQRMquality assurance strategiesrisk assessmentsGMPregulatory standardsKPI development
Soft skills
analytical thinkingeffective communicationproblem resolutionindependent decision-makingteam collaborationadaptabilitytraining deliverycross-functional stakeholder engagementprocess optimizationcontinuous improvement