Regulatory Compliance Expert

Job DescriptionWe are seeking a skilled Pharmaceutical Process Engineer - Regulatory Compliance Specialist to join our team at Novo Nordisk A/S. As a key player in the Validation Support team within the Project Quality Management (PQM) department, you will be responsible for ensuring that validation structures and processes are robust and effective.In this...

We are currently expanding our automated and digitalized facilities across all production phases, both locally and globally. Our team at FPMSAT QA sets the compliance direction for operations in transportation, intralogistics, laboratories, testing equipment, testing methods, digital solutions, robotics, and automation.Key Responsibilities:Establish and...

Fujifilm Diosynth Biotechnologies is a leading biologics contract development and manufacturing organization that combines cutting-edge expertise, capabilities, and technologies to manufacture advanced biologics.We are currently seeking a highly skilled Biologics Contract Development Expert with extensive experience in cGMP facility management to join our...

About the RoleWe are seeking a skilled Mechanical Process Expert to join our Pre-assembly and Pack team in Hillerød, Denmark. As a key member of our organization, you will be responsible for managing support improvements, upgrades, and the expansion of mechanical production equipment and capacity across our external production network.Key...

At Novo Nordisk A/S, we are seeking a highly skilled Senior GMP Expert to join our Device Manufacturing Development (DMD), Product Control and Global Support department.The successful candidate will have a strong understanding of Good Manufacturing Practices (GMP) regulations and requirements, with practical experience in the pharmaceutical industry. They...

About the Department:

Fujifilm Diosynth Biotechnologies Denmark is expanding its Quality Control department, and this presents a fantastic opportunity to join our vibrant team as a Quality Assurance Specialist for Compliance and Process Improvement.Located in Hillerød, our Quality Control department comprises approximately 230 employees across five testing teams and five support...

Responsibilities- Develop and implement quality oversight strategies for automation and IT validation activities- Collaborate with cross-functional teams to ensure compliance with regulatory requirements- Identify and resolve complex quality issues- Communicate effectively with stakeholders to achieve high-level compliance- Promote a culture of quality...

Job Overview:Compliance Specialist - Device DevelopmentWe are looking for a highly skilled Compliance Specialist to work in our Device Development team at Novo Nordisk A/S. The successful candidate will be responsible for analysing and guiding the implementation of health authorities' regulations on our marketed product portfolio. This is a challenging and...

About the Role">">As Chief Legal Advisor, you will be a key member of the Fujifilm Diosynth Biotechnologies legal team based in Hillerød, Denmark. The global FDB legal team is renowned for its expertise and collaborative approach, providing exceptional legal support to our international operations.">Your Key Responsibilities">">Contract Management">You will...

Job OverviewFujifilm Diosynth Biotechnologies is seeking a dedicated Material Handlers to join our warehouse team. As a key member of our operations, you will play a critical role in ensuring the smooth and compliant operation of our warehouse.About the RoleThis day shift position requires weekend shifts every 4th week, but we are also seeking motivated...

Job Overview\At Novo Nordisk A/S, we are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. As a senior compliance coordinator, you will play a key role in driving quality-related improvements and ensuring compliance with regulatory...

About the RoleWe are looking for an experienced Quality Assurance Specialist to join our team in Hillerød. The successful candidate will be responsible for ensuring the quality strategy is implemented and adhered to, both internally and externally.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance with regulatory...

Job SummaryWe are seeking a highly motivated Quality Assurance Manager to join our team in Hillerød. The successful candidate will be responsible for leading the quality assurance function and ensuring that all quality-related activities are executed effectively.Main ResponsibilitiesDevelop and implement quality strategies to ensure compliance with...

At FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled Contract Coordinator to join our Technical Planning & Control department.The successful candidate will be responsible for managing and maintaining external maintenance/service contracts for the Technical Operation and Support organization.As a key member of our team, you will work closely...

Global Lead for IT Compliance & Validation Apply locations Hillerod time type Full time posted on Posted 3 Days Ago time left to apply End Date: January 19, 2025 (18 days left to apply) job requisition id JR3984 As the Global Lead for IT Compliance & Validation, you will help set the overall Computerized System Validation (CSV) strategy and delivery support...

Category: Legal, Compliance & Audit Does MDR, ISO-11608, FDA 21 CFR 820.30 more than ring a bell? Are you passionate about understanding and implementing external requirements for medical devices, and working with many stakeholders across the organisation? If so, apply today and come join us as Compliance Specialist in Device Development at Novo Nordisk...

Do you have extensive experience with HPLC and Chromatographic analyses and are you eager to join a fast-growing pharmaceutical company? Now you have a unique opportunity as we are looking for a Chromatography expert/senior scientist who shares our passion, drive, and energy – what we call Genki – to join QC Chromatography. About FUJIFILM Diosynth...

Jobbeskrivelse Placering Hillerød, Denmark Jobkategori Manufacturing Ansøg nu Are you enthusiastic about mastering GMP standards and fostering a quality-focused mindset within Quality Control? Do you thrive on driving quality improvement initiatives and collaborating with diverse stakeholders in an ever-changing and growing environment, identifying the...

Are you a detail-oriented professional with an end-user focus, who is passionate about innovation in healthcare? Do you take pride in diving into the details and value coherence and consistency? Are you ready to impact Novo Nordisk’s drug delivery portfolio and impact millions of lives for our end users? If yes, you might be the new Usability Engineer to...

Select how often (in days) to receive an alert: Create Alert Experienced QA Professional for digital and automated systems validation Category: Quality Location: Hillerød, Capital Region of Denmark, DK Are you motivated by regulatory requirements and automated processes to produce, test and launch important medical devices and combination products? Do you...

Can you contribute to ensuring a smooth and compliant operation of our warehouse? And would you like to be responsible for the accurate receipt, storage, and distribution of materials to production in accordance with GMP guidelines? We are looking for dedicated and detail-oriented GMP Material Handlers, so come and join our hardworking and fun warehouse...

Jobbeskrivelse Placering Hillerød, Denmark Jobkategori Manufacturing We are looking for a new manager to join our leadership team and take responsibility for the secondary packaging Design Control Team. The team consists of currently seven senior employees, highly skilled within the field of design control and quality specification and with a can-do...

Select how often (in days) to receive an alert: Create Alert Senior Engineer for Packaging Process Development Category: Manufacturing Location: Hillerød, Capital Region of Denmark, DK Are you an Engineer willing to bring your packaging expertise to develop and support our future packaging lines globally? Do you want to be part of an innovative team that...

Select how often (in days) to receive an alert: Create Alert Process Manager, Primary Packaging Development Category: Project Management & Agile Location: Hillerød, Capital Region of Denmark, DK Do you strive to make a difference in patients’ lives? Do you want to take the lead in shaping the next process level for Development of Primary Packaging also...

Virology and Bioassay Senior Scientist Virology and Bioassay Senior Scientist Apply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3904 Do you have extensive experience with viral safety of drug substance manufacturing combined with bioassay expertise and are you eager to join a fast-growing pharmaceutical company?...

Category: Quality xx Are you ready to play a key role in building a new groundbreaking biotech Active Pharmaceutical Ingredients (API) production facility? As a QA Professional at Novo Nordisk, you’ll lead quality assurance efforts during the design and construction phases, ensuring compliance and setting quality standards. Can you handle complex...

Virologist in Material Science Would you like to provide scientific leadership in the field of Virology to support GMP manufacturing of clinical and/or commercial biopharmaceutical products? And can you onboard new customers, give input on deviations and support investigations on material-related issues? Then we hope you are our new virologist colleague in...

Do you want to play a key role in developing and improving the IT System Management and compliance processes in a Novo Nordisk manufacturing site? Do you have a strong quality mind-set combined with a wish to provide broad support within line of business? Are you motivated by working in a fast-paced and expanding manufacturing site? Then you could be our new...

The Technology Transfer (TT) Lead is a critical role within FDBD as the company is growing fast and we introduce new programs and customers continuously. So if you fit the role, we hope you will join us! Your New Role You will lead TT activities for new products into large scale manufacturing facility and coordinate and lead regular meetings for TT programs...

Are you looking for an exciting new opportunity with a fast-growing company that values your work-life balance and well-being? Take this opportunity to manage change controls within QC with a friendly and engaging team, and enjoy a competitive salary, a flexible workspace with remote work options, on-site massage sessions, access to a modern fitness center,...

Category: Manufacturing Are you motivated by managing complex manufacturing equipment and advancing our technological capabilities? If so, this is a fantastic opportunity to make a meaningful impact and leave your mark at the Factory of the Future. Apply today! The Position We have an open position in the Back Office team, where you'll join a highly...

Facility Professional / Building Constructor for Facility Management Facility Professional / Building Constructor for Facility Management Apply locations Hillerod posted on Posted 2 Days Ago job requisition id JR3889 As we continue to expand, we are looking for a motivated Subject Matter Expert within building construction and facility management who will be...

Category: Manufacturing Do you dream about managing complex manufacturing equipment and pushing the limits of our technological capabilities? Are you eager to be at the forefront, supporting the production, when something is out of the ordinary? If so, you might be the new Process Supporter for the Factory of the Future! Read on and apply today! The...

Process Supporter, Formulation, Drug Product Manufacturing Process Supporter, Formulation, Drug Product Manufacturing Apply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3598 Do you have experience from Drug product manufacturing or aseptic manufacturing? Does introducing new products into a brand-new facility...