Clinical Quality Assurance Specialist
6 days ago
Company Overview:
We are a global healthcare leader with a mission to drive excellence in clinical quality process management.
About the Job:
We are seeking a highly skilled and experienced Clinical Quality Assurance Specialist to join our team. As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process, ensuring compliance with GCP and regulatory requirements.
Key Responsibilities:
- Verify and approve Standard Operating Procedures (SOPs) and ensure compliance with external & internal requirements
- Support digitalisation of key processes and procedures
- Ensure global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
- Be the quality partner for improvement projects
- Provide support to stakeholders inside and outside R&D Quality during GCP inspections as applicable
- Attend stakeholder meetings and raise/present/discuss relevant quality concerns
- Handle and process external clinical requirements impacting the clinical area
Requirements:
- A degree in nursing, pharmacy, medicine, science or similar
- A strong command of written and spoken English
- At least 8 years of experience in clinical research and drug development, as well as a strong knowledge of GCP and other relevant regulations
- Experience with digitalization of processes to minimize risks through design and focus on quality that matters is preferred
- Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is required
- Solid experience in verifying and approving SOPs and interpreting GCP, and experience in managing compliance within clinical development
- In-depth knowledge of Veeva Vault Platform or other clinical management systems is an advantage
What We Offer:
We offer a dynamic and challenging role within clinical process management, where you will have the opportunity to work independently, leveraging your strong GCP knowledge and staying updated with changing regulations.
You will collaborate effectively with cross-functional teams and stakeholders, possessing excellent communication and presentation skills.
-
Quality Assurance Specialist
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Overview">We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.This role is part of our development...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeRole Overview:We are seeking a Regulatory Compliance Specialist to join our team. As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process, ensuring compliance with GCP and regulatory requirements.Your Key Responsibilities:Manage updates to SOPs...
-
Quality Assurance Specialist
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout AGC BiologicsAGC Biologics is a global Contract Development Manufacturing Organization (CDMO) providing comprehensive biologics manufacturing services. Our team tailors each client's needs for turnkey manufacturing or sophisticated analytical, formulation, and stability services.We have facilities in Europe, Japan, Italy, and the USA, enabling us to...
-
Quality Assurance Specialist
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout Us:At AGC Biologics, we strive to bring hope to life by enabling life-changing therapies for patients worldwide.We are a leading global Contract Development and Manufacturing Organization dedicated to improving life quality through the development and manufacturing of protein-based therapeutics and cell and gene therapies.Our Mission:To work side by...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a key member of our team, you will support CMC API Development within the raw material and CMO shipping area.Your Responsibilities:Ensure compliance with regulatory requirements, quality standards, and company policies.Deliver...
-
Quality Assurance Specialist
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Integrated Quality department, you will be responsible for overseeing quality processes and optimizing business operations across various areas within Novo Nordisk.Your primary focus will be on ensuring adherence to regulatory standards,...
-
Quality Assurance Specialist
6 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the JobWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Novo Nordisk A/S. The successful candidate will be responsible for ensuring that our quality management system is in compliance with regulatory requirements, and will play a key role in maintaining high-quality products.The position covers QA...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertGCP Advisor Specialist: Drive Excellence in Clinical Quality Process ManagementCategory: QualityLocation: Søborg, Capital Region of Denmark, DKLooking for a dynamic and challenging role within clinical process management? Do you thrive when using your in-depth GCP knowledge, process optimisation...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert GCP Advisor Specialist: Drive Excellence in Clinical Quality Process Management Category: Quality Location: Søborg, Capital Region of Denmark, DK Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your in-depth GCP knowledge, process...
-
Quality Process Manager for Clinical Trials
10 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAre you a seasoned professional looking for a new challenge? Do you have a passion for quality assurance and a desire to drive digital excellence? If so, we invite you to apply for the role of Principal GCP Advisor at Novo Nordisk A/S. About the PositionIn this role, you will be responsible for ensuring regulatory compliance when transforming written...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAs a key member of our Quality Assurance team at AGC Biologics, you will play a critical role in ensuring the quality and integrity of our products. Our team is dedicated to upholding the highest standards of quality and customer satisfaction, and we are seeking a skilled QA scientist to join us in this mission.In this role, you will support Supply Chain...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Description:">We are seeking a highly skilled Senior GCP Advisor to join our Clinical QMS department. As a key member of the team, you will be responsible for ensuring compliance with GCP and regulatory requirements.The successful candidate will have at least 8 years of experience in clinical research and drug development, as well as a strong knowledge...
-
Quality Assurance Expert
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleAt Novo Nordisk A/S, we are seeking a skilled and motivated Quality Assurance Expert to join our team. In this role, you will play a crucial part in ensuring patient safety by delivering high-quality standards for our products and production processes.The PositionAs an Aseptic Manufacturing Specialist, your primary task will be to review and...
-
Quality Assurance Professional
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled and experienced Quality Assurance (QA) professional to join our team at Novo Nordisk A/S. As a QA specialist, you will play a crucial role in ensuring the quality and safety of our products by delivering high-quality standards for production processes.The position involves reviewing and approving documents...
-
Clinical Writing Specialist
4 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAt Novo Nordisk A/S, we are committed to delivering innovative solutions for patients worldwide. As a Medical Writing Specialist, you will be part of our Clinical Reporting team, responsible for creating high-quality clinical documents that meet the highest standards of regulatory compliance.The position involves planning and preparing complex clinical...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. AGC Biologics is looking for an experienced QA scientist to assist with...
-
Associate Principal Scientist, Quality Assurance
10 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.AGC Biologics is looking for an experienced QA scientist to assist with...
-
Regulatory Compliance Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeResponsibilities:As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process, ensuring compliance with GCP and regulatory requirements.Your Key Responsibilities:Verify and approve Standard Operating Procedures (SOPs) and ensure compliance with external...
-
Quality Assurance Project Coordinator
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeQuality Assurance Project Coordinator">We are seeking an experienced Quality Assurance Project Coordinator to join our team at Novo Nordisk A/S. In this role, you will be responsible for coordinating and managing various aspects of our quality assurance processes.">Key Responsibilities">Coordinating with cross-functional teams to ensure compliance and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeCompany Overview:">At Novo Nordisk, we drive excellence in clinical quality process management. Our team of experts works closely with cross-functional stakeholders to ensure the highest standards of quality in our products.We are committed to creating an inclusive culture that celebrates diversity and promotes collaboration.Our goal is to deliver innovative...