GMP Compliance Specialist
1 week ago
The 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 department. The ideal candidate has a strong background in science, specifically in GMP from a production environment, and a minimum of 3-5 years of experience working within a regulated area. Fluency in English is essential, both written and spoken. A key aspect of this role is the ability to work independently and as part of a team, demonstrating initiative, curiosity, and a willingness to strive for process simplification. Additionally, the candidate should be familiar with the LEAN way of working and possess excellent communication skills.
About the Team
You will be joining the Chemistry Pilot Plant team at Novo Nordisk PSQIT organization, which is dedicated to developing, manufacturing, and distributing drug candidates for clinical trials. This team operates within a strong culture of collaboration, innovation, and a 'can do' mind-set, driven by a commitment to making a real difference for patients with chronic diseases worldwide.
Key Responsibilities
The main responsibilities of the GMP Compliance Specialist include:
- Driving quality-related tasks and projects across the department.
- Coordinating and implementing cross-functional quality projects where you will be the department's go-to person.
- Setting quality goals for the department and ensuring that the quality system is compliant with regulatory requirements.
Requirements
To be successful in this role, you should have:
- A bachelor's degree in Engineering, Chemistry, Pharmacy, or another relevant field.
- At least 3-5 years of experience from working within a GMP regulated area.
- Experience with the LEAN way of working/mind-set.
- Fluency in English, both written and spoken.
-
GMP Compliance Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAbout the RoleWe 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...
-
GMP Compliance Specialist
5 days 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
2 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
1 week 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
1 week 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 Analyst
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeAbout LundbeckLundbeck A/S, H is a leading global pharmaceutical company that specializes in the development and production of innovative treatments for brain disorders. Our team is passionate about making a difference in the lives of those affected by neurological and psychiatric disorders.The role you are applying for is a critical part of our efforts to...
-
GMP Compliance Specialist
1 week 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...
-
Simplified Compliance Specialist
5 days 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...
-
Pharmaceutical Compliance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark AM Group Full timeAbout the PositionWe are seeking a highly skilled Pharmaceutical Compliance Specialist to join our team in Denmark. As a member of our dedicated group, you will support one of our key clients in the pharmaceutical industry.Your responsibilities will include:Developing and implementing environmental monitoring strategies to ensure compliance with GMP...
-
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...
-
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...
-
Cyber Security Compliance Expert
2 weeks ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeJob DescriptionHays Specialist Recruitment is seeking a highly skilled Cyber Security Compliance Expert to join our team. As a key member of the organization, you will be responsible for ensuring that our embedded software and OT systems meet all relevant security and compliance standards.About the RoleThis senior-level position requires a minimum of 5 years...
-
GMP Quality Assurance Expert
1 day 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
1 week 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
5 days 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
7 hours 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
3 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
1 week 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
24 hours 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
1 week 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...