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If InsuranceSenior Quality Engineer
Senior Quality Engineer ensuring high - quality web applications. Collaborating in Agile teams within the Nordic insurance sector to enhance software quality and user experiences.
About the role
- Provide overall strategic oversight for global GCP, GVP, & GLP QA activities, ensuring collaborative and compliant implementation of initiatives with all internal and external partners.
- Act as a senior strategic partner to Clinical Development, Pharmacovigilance, and Non-Clinical leadership.
- Lead and provide technical direction for all Health Authority inspections (GCP, GVP, GLP), including preparation, hosting, and ensuring robust and timely responses to any findings.
- Develop and execute the risk-based GCP/GVP/GLP audit strategy for all internal processes, investigator sites, and external service providers, and oversee the execution of the comprehensive audit program.
- Drive continuous improvement by leveraging QMS data, monitoring KPIs, and analysing risk.
- Oversee the CAPA process to ensure effective solutions and maintain all GCP/GVP/GLP QA processes, standards, and the associated compliance training program.
- Implement risk-based quality approaches for clinical development programs and provide ongoing quality risk monitoring.
- Monitor major regulatory updates and industry trends, benchmarking through professional consortia and networking to identify and lead necessary change management opportunities.
Requirements
- Bachelor’s degree in a scientific field.
- Minimum 10 years of pharmaceutical/biotechnology drug development experience, with at least 10 years in GCP, GVP, and GLP QA compliance.
- Expert-level knowledge in leading Health Authority inspections (GCP, GVP, GLP) and managing global, risk-based audit programs.
- In-depth, applied knowledge of applicable GCP, GLP, and GVP regulations and ICH guidelines.
- Proven track record of strong people management and the ability to build and develop a high-performing team.
- Outstanding communication, presentation, and influencing skills, with a demonstrated ability to hold senior leaders accountable and navigate complex problems.
- Strong risk management expertise, including issue identification, problem-solving, and decision-making.
- Working knowledge of all Clinical Development phases and processes.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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