GCP Advisor Specialist, Clinical QA

Jobtailor; Søborg; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Jobtailor in Søborg, Denmark is seeking an experienced Senior Quality professional to provide expert GCP guidance across global clinical development. You will lead cross-functional initiatives to strengthen quality and compliance, conduct vendor assessments, and manage CAPA/change control with focus on serious breaches.

Responsibilities include training and knowledge sharing, supporting inspection readiness, and influencing quality culture across the organisation with interactions across

Qualifications

• A degree in medical, biological, pharmaceutical sciences or another relevant scientific discipline.
• Extensive experience within GCP, clinical trial regulations, quality management systems, and clinical development (10+ years).
• Strong understanding of drug development processes, lifecycle management, and regulatory approval requirements.
• Experience leading projects and cross-functional initiatives in a global organisation.
• Excellent communication and stakeholder management skills, with the ability to present complex quality topics clearly.
• Proactive, collaborative, and adaptable with a risk-based approach to quality.
• Ability to influence stakeholders across functions and organisational levels.

Responsibilities

• Provide expert GCP advice and quality guidance to stakeholders across global clinical development.
• Lead cross-functional improvement initiatives and projects to strengthen quality and compliance.
• Perform vendor assessments.
• Manage CAPA and Change Control review and approval, and handle serious breaches.
• Train, support, and ensure knowledge sharing of quality issues and processes.
• Contribute to regulatory inspection readiness and support interactions with health authorities globally.
• Influence processes, decision-making, and quality culture across the organisation.

Skills

GCP expertise

Quality management

Regulatory inspection readiness

Stakeholder management

Project leadership

Quality culture

Education

Degree in medical/biological/pharmaceutical sciences

Job description

• Provide expert GCP advice and quality guidance to stakeholders across global clinical development.
• Lead and participate in cross-functional improvement initiatives and projects to strengthen quality and compliance.
• Perform vendor assessments.
• Manage critical quality processes, including CAPA and Change Controls review and approval, and handle serious breaches.
• Train, support, and ensure knowledge sharing of quality issues and processes.
• Contribute to regulatory inspection readiness and support interactions with health authorities globally.
• Influence processes, decision-making, and quality culture across the organisation.
• Partner with Development, Research & Early Development, Global Regulatory Affairs, Global Safety, Clinical Drug Development, Clinical Vendor Management & Compliance, and other key functions.
• Strengthen quality systems, optimise processes, and enable successful development of innovative treatments.

Requirements

• A degree in medical, biological, pharmaceutical sciences or another relevant scientific discipline.
• Extensive experience within GCP, clinical trial regulations, quality management systems, and clinical development, ideally with 10+ years of relevant experience.
• Strong understanding of drug development processes, lifecycle management, and regulatory approval requirements.
• Experience leading projects and driving cross-functional initiatives in a global organisation.
• Excellent communication and stakeholder management skills, with the ability to present complex quality topics clearly and effectively.
• Proactive, collaborative, and adaptable.
• Sound judgement and a risk-based approach to quality.
• Ability to influence stakeholders across functions and organisational levels.

Core Competencies

Demonstrates extensive expertise in GCP, clinical trial regulations, and quality management systems, with a strong focus on stakeholder engagement and cross-functional collaboration to enhance quality processes and compliance in clinical development.

Highest-signal resume keywords

• GCP Expertise
• Quality Management Systems
• Regulatory Inspection Readiness
• Stakeholder Management
• Project Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Trial Regulations
• CAPA Management
• Change Control Review
• Drug Development Processes
• Lifecycle Management

Soft Skills

• Excellent Communication
• Proactive Collaboration
• Adaptability
• Sound Judgement
• Influencing Skills

Industry Keywords

• Clinical Development
• Quality Culture
• Vendor Assessments
• Global Regulatory Affairs
• Health Authorities