GMP Compliance Specialist
2 days ago
Genmab is an innovative biotech company dedicated to transforming the lives of people with cancer and other serious diseases through cutting-edge antibody medicines.
About the RoleThis GMP QA Manager position offers a unique opportunity to contribute to the development and delivery of novel antibody therapies to patients.
Key Responsibilities- Ensuring the quality oversight of starting materials, intermediates, and drug substances for commercial products.
- Collaborating with Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.
- Maintaining and continuously improving Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
- Acting as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance).
- Supporting Quality Management Review and Annual Product Review.
- Developing and implementing QA strategies to ensure compliance with GMP/GDP-regulations and guidelines.
Our commitment to diversity, equity, and inclusion is at the heart of everything we do, and we're passionate about creating a workplace where everyone feels valued and empowered to succeed.
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GMP Compliance Expert
4 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking an experienced GMP Compliance Expert to join our Internal Audits department. As a GMP Compliance Expert, you will be responsible for auditing Novo Nordisk GMP regulated areas worldwide.Main Responsibilities:Initiate and prepare audits.Conduct and report on routine, for cause, process, and qualification audits.Share knowledge of...
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Cyber Security Compliance Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeJob DescriptionWe 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.Your Key ResponsibilitiesDevelop and implement cyber security compliance programs for...
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Senior Cyber Security Compliance Specialist
2 days 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...
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Compliance and Risk Manager
2 days ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeAbout Our TeamWe are looking for a highly skilled and experienced Cyber Security Compliance Specialist to join our team. As a key member of our team, you will play a critical role in ensuring the security and compliance of our clients' embedded software and OT systems.Your Key ResponsibilitiesDevelop and implement comprehensive cyber security compliance...
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Lead Auditor with solid GMP experience
4 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeAre you an experienced Quality Auditor or specialist and skilled within GMP? Do you have pharmaceutical or related industry knowledge? Are you highly skilled in ISO/GMP and ready for the next step of your career? Then you can be part of a life-changing career in Novo Nordisk Internal Audits. The position As our new Lead Auditor, you will join our Internal...
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IT Support Specialist
7 days ago
Copenhagen, Copenhagen, Denmark Excis Compliance Full timeCompany OverviewExcis Compliance Ltd. is a global leader in IT services, delivering excellence in desktop support, network management, and IT solutions to Fortune 500 companies and growing businesses alike. Our presence in over 100 countries enables us to combine local expertise with a global vision, ensuring the best IT services for our clients.
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Manager, QA GMP
2 days 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...
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Compliance Assurance Specialist
15 hours ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeA company overview: PARETO SECURITIES AS is dedicated to safeguarding the digital infrastructure that supports millions of people. Our mission is to maintain a culture of expertise, inclusion, and growth where people matter.As a Compliance Assurance Specialist at PARETO SECURITIES AS, you will play a critical role in ensuring the organization's compliance...
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Regulatory Compliance Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled and experienced professional to join our team as a Quality Coordinator - Chemistry Pilot Plant. In this role, you will be responsible for ensuring the quality and integrity of our products throughout the development and manufacturing process.Your Key ResponsibilitiesDevelop and implement quality management...
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Project Engineering Specialist
1 day ago
Copenhagen, Copenhagen, Denmark AM Group Full timeAre you passionate about process optimization and manufacturing excellence? Do you have experience in leading cross-functional teams and ensuring compliance with regulatory requirements?As a Project Engineering Specialist at AM Group, you will play a key role in designing, developing, and optimizing manufacturing processes for our clients in the...
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Compliance Specialist
2 days ago
Copenhagen, Copenhagen, Denmark ComplyCloud ApS Full timeWe are an award-winning LegalTech-SaaS company empowering businesses to achieve seamless compliance and build trust with simplified data protection and IT security.As a key member of our team, you will master the process of identifying prospects using tools like Salesforce and Cognism. You will reach out to future customers, showcasing a solid understanding...
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Upstream Process Development Specialist
1 day ago
Copenhagen, Copenhagen, Denmark AGC Biologics Full timeWe are looking for an experienced Upstream Process Development Specialist to join our Clinical Team in Manufacturing Product Support department. As a key member of our team, you will be responsible for developing and implementing upstream processes for clinical products, ensuring compliance with GMP regulations.The ideal candidate has experience working in a...
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Regional Compliance Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Getinge Full timeAt Getinge, we are committed to making life-saving technology accessible for more people. As a Regional Compliance Specialist, you will play a vital role in enabling and supporting our organization in managing risks and shaping the way business is conducted.We are looking for an experienced professional who can lead and oversee the implementation and...
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Compliance Training Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeWe are looking for a Compliance Training Specialist who can infuse creativity into both GXP and non-GXP training programs for our colleagues consisting of specialists within their field. As a key member of our IT Quality & Compliance team, you will establish key performance indicators (KPIs) and design metrics to evaluate the effectiveness of training and...
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Senior IT Compliance Specialist
7 days ago
Copenhagen, Copenhagen, Denmark JSS Associates Full timeAs a Senior IT Compliance Specialist at JSS Associates, you will be responsible for defining and executing validation and qualification strategy for the development and implementation of Genetics Analysis Platforms. This is a long-term contract based in Copenhagen, Denmark.The role involves ensuring that systems are in compliance with relevant internal and...
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Investigation and Compliance Specialist
3 days ago
Copenhagen, Copenhagen, Denmark FLSmidth Full timeInvestigation and Compliance Specialist Apply locations Copenhagen, Capital Region, Denmark time type Full time posted on Posted 4 Days Ago time left to apply End Date: March 20, 2025 (16 days left to apply) job requisition id R26771 Investigation and Compliance Specialist – Compliance FLS is a leading, minerals processing supplier to the global mining...
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Compliance Specialist
3 days ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeSom Compliance Specialist i 3, bliver du en del af vores engagerede GRC-team (Governance, Risk og Compliance) - en vigtig del af Legal & Regulatory. Vi leder efter en energisk kollega, der brænder for både compliance og forretningsudvikling – og som vil være med til at drive og videreudvikle policy governance på vores vigtigste complianceområder. Er...
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Compliance Data Specialist
4 days ago
Copenhagen, Copenhagen, Denmark PureGym DK Full timePureGym DK is looking for a highly skilled Compliance Data Specialist to join our Data & Consumer Compliance team. As a key player, you'll be responsible for delivering our data compliance program across the organization.You'll work closely with the Head of Data and Consumer Compliance and other colleagues from IT, Marketing, and Operations teams to ensure...
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Senior Bioassay Specialist
3 days ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeSenior Bioassay SpecialistWe are seeking an experienced Senior Bioassay Specialist to join our team in QC General Analytics. The successful candidate will have a strong background in bioanalytical sciences and experience in method validations, regulatory compliance, and quality assurance.The ideal candidate will be responsible for ensuring the accuracy and...
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Data Compliance Specialist
4 days ago
Copenhagen, Copenhagen, Denmark PureGym DK Full timeWe're searching for a Data Compliance Specialist to join our Data & Consumer Compliance team About the Team The Data & Consumer Compliance team plays an important role in the organisation, being a business partner and providing support to each of our operating markets and central teams. The team provides expertise to ensure that the business is protected...