GMP Compliance Specialist
2 weeks ago
About the Role
We are seeking a highly skilled GMP Compliance Specialist to join our team at Novo Nordisk A/S. As a Senior Quality Assurance Leader, you will play a critical role in ensuring adherence to Good Manufacturing Practice (GMP) compliance requirements and best practices across all operations in Local Manufacturing.
In this position, you will provide support and direction to Line of Business at local sites, including their GMP and/or Quality partners. You will be responsible for site and project support, deviation handling, quality improvements initiatives, and GMP activities.
Your key tasks will include:
- Providing Site & Project Support to our Local Manufacturing Sites, within deviation handling, quality improvements initiatives, and GMP activities.
- Leading and overseeing the management of more complex deviations; ensuring timely investigations, systematic problem-solving, and appropriate corrective actions are implemented.
- Ensuring adherence to GMP compliance requirements and best practices sharing across all operations in LM.
- Guiding, training, and coaching sites on effective deviation handling practices to enhance compliance and operational efficiency.
Requirements
To succeed in this role, you must have:
- A minimum bachelor's degree in natural science, engineering, or a similar field.
- Minimum +3 years of GMP experience from the pharmaceutical industry, such as tablets, assembly, or packaging of finished products.
- Proven experience with LEAN and effective systematic problem-solving methodologies.
- Full professional proficiency in English, while having proficiency in Danish is nice to have.
About the Department
Local Manufacturing - Projects and Site Support is part of LM Business Support, Denmark. Our primary role is the establishment and operation of local manufacturing sites in countries where local presence is required to obtain market access.
We oversee our local production sites in Algeria, Russia, Iran, and Japan and provide quality and project support to our local factories on a daily basis. The Project and Site Support team consists of specialists, professionals, and project managers providing support and guidance within Quality, Audit and Inspections, and Production Processes (FPM).
We have high ambitions and aim, as a team, to raise the quality and performance level at our Local Sites. We are 23 employees in the entire department in Denmark, and we are currently located in Bagsværd.
-
GMP Compliance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeJob SummaryThe GMP Compliance Specialist plays a critical role in ensuring that the Chemistry Pilot Plant at Novo Nordisk PSQIT organization meets all regulatory requirements. This includes driving quality-related tasks and projects across the department, coordinating and implementing cross-functional quality projects, and setting quality goals for the...
-
GMP Compliance Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout UsAt Genmab, we're dedicated to transforming the lives of patients through innovative and differentiated antibody therapeutics. We believe in the importance of teamwork, innovation, and expertise in driving success.About the RoleWe're seeking a highly skilled GMP QA Manager to join our team, responsible for quality oversight of starting materials,...
-
GMP Compliance Engineer
6 days ago
Copenhagen, Copenhagen, Denmark Optimus Life Sciences Full timeGMP Compliance Engineer PositionOptimus Life Sciences seeks a skilled GMP Compliance Engineer to join our team in Copenhagen, Denmark. As a key member of our engineering team, you will be responsible for maintaining GMP compliance for the engineering department.About the Role:This role involves ensuring that all commissioning procedures are completed to...
-
GMP Compliance Expert
2 weeks ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeWe are seeking a talented Senior Scientist to join our Quality Assurance team as a GMP Compliance Expert. In this role, you will be responsible for ensuring the quality and compliance of our biopharmaceutical production processes.Your Key Responsibilities:Develop and implement quality management systems to ensure continuous improvement.Collaborate with...
-
GMP Compliance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Position"> We are seeking a highly motivated and experienced Regulatory Affairs professional to join our team as a Pharmaceutical QA Lead. The successful candidate will be responsible for ensuring compliance with EU and US regulations, reviewing and authoring QMS SOPs, Work Instructions, and other documents, and supporting Quality Management...
-
GMP Compliance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAbout UsWe are part of the Novo Nordisk PSQIT organization, Chemistry, Manufacturing and Control (CMC) Product & Process Development, making a real difference for patients with chronic diseases across the world.We develop, manufacture, and distribute drug candidates for clinical trials and have a strong culture with a 'can-do' mindset. The cell banks in Novo...
-
Cyber Security Compliance Specialist
4 hours ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeJob Description:We are seeking a highly skilled and experienced Senior Cyber Security Compliance Specialist for our client in the industrial and manufacturing engineering industry. In this role, you will be responsible for ensuring that embedded software and OT systems meet all relevant security and compliance standards.You will work closely with...
-
Simplified Compliance Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Impero - Compliance. Simplified. Full timeAbout UsImpero is a rapidly growing SaaS company that specializes in financial and tax compliance for businesses.We serve top-tier clients and industry leaders, and our platform helps simplify financial and tax teams document risks, set up corresponding internal controls, and report on control status.We offer a collaborative work environment that values...
-
Senior Cyber Security Compliance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeFreelanceprojektDenmarkStartdato: så hurtigt som muligtReferencenummer: 780901/1OpgaverWe are seeking a highly skilled and experienced Senior Cyber Security Compliance Specialist for our Client. In this role, you will be responsible for ensuring that our embedded software and OT systems meet all relevant security and compliance standards. You will work...
-
Senior Cyber Security Compliance Specialist
5 hours ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeFreelanceprojekt Denmark Startdato: så hurtigt som muligt Referencenummer: 780901/1 Opgaver We are seeking a highly skilled and experienced Senior Cyber Security Compliance Specialist for our Client. In this role, you will be responsible for ensuring that our embedded software and OT systems meet all relevant security and compliance standards. You will...
-
Compliance Manager for Embedded Systems
2 weeks ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeCompliance Manager for Embedded SystemsHays Specialist Recruitment is seeking a highly skilled Compliance Manager for Embedded Systems to join our team.About the RoleThis role requires a strong understanding of risk management, compliance, and associated frameworks.You will be responsible for conducting IT and information security risk assessments to...
-
GMP Quality Assurance Expert
5 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAbout This OpportunityWe are looking for a Production and Process Specialist who can make a meaningful contribution to our team's mission. As a key player, you will be instrumental in shaping our local manufacturing operations, driving process improvements, and ensuring high-quality standards.In this role, you will have the opportunity to:Work closely with...
-
Senior GMP Supporter
2 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Would you like to take the next exciting step in your career by playing a key role in a dynamic and impactful business support unit, driving meaningful change in Local Manufacturing production? Does using your hands-on expertise in deviation handling and cGMP to tackle tasks, enhance processes, and...
-
GMP Assurance Expert
1 week ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeWe are looking for a highly motivated and experienced QA professional to join our team as an Advanced QA Professional. The ideal candidate will possess a strong understanding of GMP regulations and quality assurance principles, as well as excellent communication and interpersonal skills.The successful candidate will be responsible for ensuring best-in-class...
-
Senior Cyber Security Compliance Expert
4 days ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeHays Denmark is seeking a highly skilled Senior Cyber Security Compliance Specialist to ensure our embedded software and OT systems meet all relevant security and compliance standards.This role requires close collaboration with cross-functional teams and management to develop, implement, and maintain security policies, procedures, and controls.The ideal...
-
Compliance Specialist
6 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeWe are seeking a talented Compliance Specialist to join our Emerging Technologies API Manufacturing Development (ET API MDev) team at Novo Nordisk A/S.As a Compliance Specialist, you will play a key role in ensuring compliance with GxP guidelines and regulations, and supporting the development and implementation of processes and procedures to ensure quality...
-
Analytical Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAbout the Role:We are seeking an experienced Analytical Specialist to join our GMP laboratory. The successful candidate will be responsible for ensuring the quality of analytical procedures for new injectable drug products.The role involves supporting chemical analysis of injectable drug products, both internally in the department and globally in QC...
-
Outsourced GMP Activities Quality Manager
4 days ago
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time**About the Role**We're seeking a talented **Outsourced GMP Activities Quality Manager** to join our QA team in Copenhagen. In this role, you'll be responsible for managing quality oversight of outsourced development activities, ensuring compliance with regulatory requirements and industry standards.Main responsibilities will include:Developing and...
-
Manager, QA GMP
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
GMP Process Engineer
2 weeks ago
Copenhagen, Copenhagen, Denmark European Tech Recruit Full timeAs a Process Specialist at European Tech Recruit, you'll be responsible for designing, specifying, and overseeing the installation of new process equipment. You'll provide technical support and troubleshooting for Upstream (Cell Culture), Downstream (Purification), Clean Utility/CIP, and Solution Preparation systems.About the Job FunctionThe ideal candidate...