QA GCP/PV
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
København
Job Summary
About Us Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
The Role You will work in a multidisciplinary international QA team to ensure compliance to industry standards and regulations. As Associate Director, GCP/PV you will conduct audits internally as well as externally at our CRO’s and collaborators. You are responsible for writing audit reports and review audit responses to audit closure. In addition, you will provide support to the clinical teams regarding GCP and regulatory requirements within the area of clinical trials conduct and be the acting chair in SOP committees.
As part of the QA department, you are an active collaborator within Genmab.
Key Accountabilities The responsibilities of the Associate Director, GCP/PV will include, but not be limited to:
- Be an active QA representative in both the early and late stage clinical development and for the marketed products, including oversight of GCP and Drug Safety activities globally
- Plan, perform and follow-up on Quality Audits within GCP and Drug Safety/PV regulated areas both internally and externally and perform vendor evaluations
- Represent QA in clinical project groups or clinical sub groups and participate in cooperation with partners and contractors as appropriate
- In addition to this, the employee shall provide internal QA support in the organization and prepare/coordinate
- Participate in GCP/PV inspections performed by national authorities
- Clinical and drug safety/PV Quality Agreements
- Participate in the development and maintenance of the existing Quality Management System (QMS) and associated GCP and PV SOPs
- Participate in knowledge sharing by gaining and maintaining expert knowledge about new GCP and drug safety guidelines, clinical trials laws, legislations and practices, including informing relevant parts of the organization
- Participate in training and education of employees in the GCP, drug safety and other relevant guidelines and regulations, and ensure oversight of the company’s clinical trials is conducted in compliance with clinical protocols, GCPs and other regulatory requirements
- Experience with oncology will be beneficial
Skills & Experience
- You hold an MSc in Pharmacy or a related scientific degree, or alternatively otherwise medically trained
- You have more than five years relevant industry experience in the GCP and Drug Safety areas working in a Quality department
- You have experience in SOP training
- You have experience working in an EDMS system, such as Veeva Vault document management
- You have excellent communication skills in both English and Danish, and a collaborative mind-set
- Experience of oncology, late phase, pharmacovigilance, and/or first in human trials would be beneficial
- You are willing to travel globally for up to 20% of your work schedule
- Trained auditor is beneficial
Other Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
To learn more about Genmab, you can visit our website: http://www.Genmab.com/
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 7.11.2019, men kan have været deaktiveret og genaktiveret igen.
- Afdelingsleder
- København
Lignende jobs
-
Head of Personal Banking Legal DK
Job ID: 26778 We are looking for a leader to join the legal department in one of the largest banks in the Nordics. You’ll be leading a team of highly skilled lawyers supporting the business ar..Få mere info- Afdelingsleder
- København S
-
Head of Global Academy
We are seeking a creative and experienced leader to our Global Academy in digital dentistry education to develop and support the strategic development and implementation of learning and trainings s..Få mere info- Afdelingsleder
- København
-
Chartered Asset Reliability Manager
Opportunity Maersk is on an exciting journey to become the world’s global integrator of container logistics and decarbonize the shipping industry. As a company, we offer a truly global environmen..Få mere info- Afdelingsleder
- København K
-
Global Head of Operations, Energy Markets
Opportunity A.P. Moller - Maersk is an integrated logistics company responsible for moving 20% of global trade annually. With a dedicated team of over 100,000 employees across 130 countries, we g..Få mere info- Afdelingsleder
- København K
Statistik over udbudte jobs som afdelingsleder i København
Herunder ser du udviklingen i udbudte afdelingsleder i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal afdelingsleder i København.
Se flere statistikker her:
Statistik over udbudte afdelingsleder i København over tid
| Dato | Alle jobs som afdelingsleder |
|---|---|
| 12. november 2024 | 184 |
| 11. november 2024 | 186 |
| 10. november 2024 | 187 |
| 9. november 2024 | 187 |
| 8. november 2024 | 200 |
| 7. november 2024 | 198 |
| 6. november 2024 | 194 |
| 5. november 2024 | 191 |
| 4. november 2024 | 186 |
| 3. november 2024 | 191 |
| 2. november 2024 | 191 |
| 1. november 2024 | 188 |
| 31. oktober 2024 | 199 |
| 30. oktober 2024 | 199 |
| 29. oktober 2024 | 202 |
| 28. oktober 2024 | 203 |
| 27. oktober 2024 | 202 |
| 26. oktober 2024 | 206 |
| 25. oktober 2024 | 169 |
| 24. oktober 2024 | 200 |
| 23. oktober 2024 | 204 |
| 22. oktober 2024 | 199 |
| 21. oktober 2024 | 197 |
| 20. oktober 2024 | 202 |
| 19. oktober 2024 | 202 |
| 18. oktober 2024 | 203 |
| 17. oktober 2024 | 207 |
| 16. oktober 2024 | 210 |
| 15. oktober 2024 | 205 |
| 14. oktober 2024 | 202 |
| 13. oktober 2024 | 199 |
Værd at vide når du søger job som afdelingsleder i København
Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.
Bydele i København
København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:
Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.
Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.
Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.
Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.
Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.
Find ledige jobs i Valby
Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.
Mere information om København
Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer