16 job matcher din søgning
Symphogen A/S, Ballerup
Symphogen is currently experiencing an increase in activities within both the early and late stage projects. Furthermore, Symphogen is planning to start phase III clinical trials and to apply for a Manufacturing and Import Authorization (§39 Licence).
Symphogen therefore plans to strengthen the QA organization with a Quality Manager.
As Quality Manager you will be involved in every step of the manufacturing process from generation of cell banks, upstream and downstream processes, final formulation, filling, analysis and release of the final drug product. The manufacturing is outsourced to various CMO's in EU and US.
The Quality Manager will participate for the quality group in our projects covering process and analytical validation, PPQ, clinical supply, and eventually marketing application.
FMC Corporation, Hørsholm
Based in our new established European Innovation Center in Hørsholm, you will be responsible for managing the sourcing of FMC’s requirements for the Commodity Chemicals and Functional Additives portfolios for all sites in the EMEA region.
Together with the Global Category Managers you will develop and implement strategies, manage key supplier relationships, coordinate the issuance of forecasts and volume allocation, and other internal communications regarding materials in the pertinent categories.
- Understand FMC’s businesses and work closely with the main stakeholders to align sourcing requirements to business strategies.
- Indentify and implement savings and working capital opportunities via synergies between plants and businesses, particularly within the European sites.
LEO Pharma, Ballerup
Are you passionate about optimising business performance through compliance? Do you want to help create a new way of implementing compliance to make it a natural part of our regional culture? And are you ready to do so across four continents?
America, the Middle East, Africa and Russia. Over the past year we have intensified our focus on developing our regional QA & Compliance frameworks, and driving compliance as a recognised and basic cultural element across the region. Now it is time to take our efforts to the next level – and this is where you come in to the picture. In close collaboration with the Regional Senior QA & Compliance Manager, you will optimise and drive the QA & Compliance processes across the region with a strong commercial and cultural focus.Your primary tasks will be to:
- Continue to develop GxP and Non-GxP Compliance
- Consolidate and follow up on Non-GxP compliance
Would you like to use your quality competences in a holistic and pragmatic way, by being a part of growing the ALK business and meeting the needs for people with allergy earlier in their allergy journey?
If you enjoy new challenges, where you need to use your professional approach to quality as well as your personal skills to obtain results together with internal and external stakeholders, this is your next position.
In this exciting position, your quality competencies and experience will come into play, as you will be involved in setting the standard for quality activities related to new business opportunities. You will be part of the ALK Global Quality, Markets & Inspections department, an experienced team that works closely on quality aspects with internal and external collaborators from many different cultures.
You will be responsible for preparing, leading and implementing the regulatory development strategies of both small and large molecules for development projects with a high degree of complexity. You will represent RA in the global cross-functional project teams where you will focus on identifying regulatory opportunities and creating regulatory pathways for novel development directions within CNS.
In a typical day, your activities will range from discussing development strategy with the clinical lead, preparing for health authority interactions, looking into evidence generation strategies with your HEOR colleague, chairing a team meeting with your regulatory colleagues from key markets, to presenting a submission strategy for the cross-functional project team and/or Executive Management and Business Partners.
Signium International Danmark recruiting on behalf of GSK Pharma in Brøndby
On behalf of GSK Pharma, we are looking for a Quality Lead to join the quality team in Denmark and Nordic Cluster – consisting of Denmark, Island, Finland, Norway and Sweden. The position is based in Brøndby in the outskirts of Copenhagen.
You will be responsible for the Quality oversight of GSK prescription medicinal products distributed in Denmark and Iceland. You will act as the Responsible Person of GSK Pharma in Denmark as defined by the European Good Distribution Practice (GDP) guidelines.
The focal point of the position is quality strategy and quality systems, covering all GDP (Good Distribution Practice) areas such as deviation handling, self-inspections/audits, change control, risk management, product distribution, third party management, as well as product complaints/defects/recalls.
Novartis Healthcare A/S, Sweden, Finland, Norway or Denmark
Do you want to work for a Global Pharmaceutical company where you will be recognized for your contribution and commitment? Look no further, apply today for Cell & Gene Therapy Center Strategic Mgr.
The position engages across the manufacturing and supply functions and the patient/physician facing commercial and medical teams across the hospital sites supporting CAR-T products and is responsible the complete ramp-up of identified hospital sites into fully certified and compliant treatment delivery and manufacturing locations.
The purpose of the Cell & Gene Therapy Center Strategic Mgr. role is to develop, coordinate and implement a strategic business plan for certified CTL019 Centers including KOLs within the centers. Educate hospital administration on the value proposition of CTL019 to gain access at hospital/site.
Clinical Supply Packaging (CSP) søger en dygtig operatør. CSP er en del af Finished Goods Production (FGP) og er fysisk placeret i Lundbecks hovedkvarter i Valby. CSP varetager pakning af Investigational Medicinal Products (IMP) til Lundbecks kliniske forsøg. FGP består udover CSP af afdelingen Commercial Packaging, som varetager pakning af Lundbecks kommercielle produkter.
Teamet varetager produktion af kliniske pakninger samt dokumentation af produktionsforløbet. Din primære opgave er at varetage produktion på en pakkelinje i samarbejde med kolleger. Jobbet består hovedsageligt af pakning på de 2 automatiske pakkelinjer, håndpakning, blindingsvurdering, proceskontrol, omstilling, rengøring, og løbende dokumentation af disse aktiviteter. Vi arbejder efter GMP-regler.
ALK is looking for a Medical Doctor to join the Global Medical Affairs team as Global Medical Affairs Manager in the Company Headquarters.
ALK is the world leading pharmaceutical company within the field of allergy. ALK is devoted to improving the lives of people with allergies by developing products that target the underlying cause of allergy. At ALK, we are pioneering the development of a range of tablet-based immunotherapy products, and setting new standards for evidence-based treatment decision-making within the field of respiratory allergic disease.
Field of responsibility
- Obtain, interpret, and apply guidance from medical and scientific Experts
- Provide pivotal medical scientific input and informed opinion to the allergy clinical development pipeline
- Plan, drive, and coordinate the global publication strategy
Do you want to influence the future of global Healthcare Professional (HCP) customer engagement at Novo Nordisk?
Novo Nordisk, Søborg
To help us meet our ambitions and provide the best solutions to patients, UCB is currently seeking a talented individual as: Country Market Access Lead...
UCB S.A., København