*Manager for QA Material Management Team

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

København

Are you a manager with experience within raw material and supplier management looking for a new career opportunity? Do you enjoy working cross-functionally across all levels of internal clients? Our quality organization is growing, and we are looking for a new colleague. If you like continuous development and growth AGC Biologics is the place to be.

About the Role

You will be responsible for the daily management of a team of highly qualified scientists and Subject Matter Experts.

You will be overall responsible for the quality oversight for our cGMP Material Management area, approved according to the European Directive 2001/83/EC, 2017/1572 as well as FDA 21 CFR 210 and 211, as well as the ICH Q7 guideline. Your area of responsibility will include supporting the current manufacturing facility and the new expanded facility.

At AGC, we use a risk-based approach to keep our policies updated with current regulatory expectations as well as business expectations. In the QA Material Management team this is done in close collaboration with our stakeholders in Manufacturing, Quality Control, Supply Chain Management, Process Validation, Process Transfer, and Development.

You will be actively involved in the constant development within our field and the continuous improvement of our quality system. Ensuring that the internal stakeholders comply with standards for cGMP production, i.e., EU GMP, CFR 21 and ICH guidelines, and you will be an important collaborator on defining worldwide policies as well as ensuring quality oversight and compliance of procedures.

You will work with the Supplier Qualification team responsible for the supplier management program, supporting the site manufacturing of clinical and commercial drug substances. This role requires attention to detail, organization, and comfort in interacting cross-functionally with internal and external partners.

About the QA Material Management Team

The QA Material Management team is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience in quality assurance.

You will cover strategic and tactical leadership for the QA Material Management team and be responsible for procedures and policies for material qualification as well as compliance for GMP materials to applicable international regulatory requirements. Additionally, the team is an active contributor to customer audits and regulatory inspections.

Principal Responsibilities:

  • Provide leadership and vision to drive a quality culture by developing a risk-based quality strategy to ensure business goals.
  • Ensuring a staff training program and a talent management program for the team.
  • Budget responsible for the department.
  • Overall responsible for ensuring quality oversight for the GMP Material Management area.
  • Ensure effective and compliant material qualification processes and engage in cross-functional planning to leverage resources to improve the speed of resolution.
  • Partner with community peers at the operational sites to share and adopt best practices across the AGC network to drive continuous improvement.
  • Align local procedures and policies with global policies. Partner with global quality teams to set a “state of art” policy for GMP material qualification, procurement, storage, validation, and use.
  • Routinely participate in internal and external audits and inspections.
  • Contribute to Annual Product Review and BLA process for commercial projects.
  • Ensure execution of Approved Supplier Program for the site.
  • Optimize the supplier quality program through management of or participation in continuous improvement projects.

Qualifications:

A manager with analytical and problem-solving skills. Strong decision-making skills and a “can do” attitude. The ability to work in a fast-paced, matrix environment is essential. Capable of working on short deadlines and prioritizing multiple tasks. Flexibility to meet changing needs and business priorities. Strong ability to work independently.

You will recognize the following:

  • Expertise in regulatory requirements for a risk-based approach to GMP material management.

  • Skilled in strategic thinking, communication and negotiation.
  • Actively develops and maintains strong professional relationships building trust and respect across the organization.
  • Lead through influence, effectively build alignment and collaborate with multiple stakeholders.
  • Facilitate organizational change related to validation across multiple functions.
  • Identify performance roadblocks and develop appropriate solutions.

Education/Experience:

  • Sc. in chemistry or life sciences or equivalent experience.
  • 10+ years of relevant experience in a pharmaceutical or GMP environment.
  • Direct experience in team management is required.
  • Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated.

For further information, please contact Lise Marie Christensen at [email protected]

For agencies, please contact our Talent Acquisition team at [email protected]

#JobsForUkraine

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 28.7.2022, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • København
Rapportér

Lignende jobs

  • Senior Associates og Managers til Transaction Advi...

    Fri kontakt
    Senior Associates og Managere til Transaction Advisory Service i København. Vi mærker en stigende efterspørgsel efter rådgivning i forbindelse med køb og salg af virksomheder, herunder finansiel due diligence. Derfor søger vi Senior Associates og Managere til vores TAS team på Østerbro.
    • Øvrige
    • København
    Få mere info

  • Øvrige i Frederiksberg C

    Fri kontakt
    Se https://www.digitaldisruptionmedia.com/jobs/piccolinepiccolo-sges-snarest
    • Øvrige
    • Frederiksberg C
    Få mere info

  • Politisk konsulent til offentligt-privat samarbejd...

    Fri kontakt
    Er du en initiativrig og passioneret konsulent, der brænder for at fremme samarbejdet mellem offentlige og private aktører? Vil du være med til at styrke danske virksomheder og bidrage til innovative og bæredygtige løsninger? Så er det dig, vi søger til en spændende stilling hos DI! Om jobbet.
    • Øvrige
    • København V
    Få mere info

  • Konsulent til DI's AI for Alle indsats

    Fri kontakt
    Dansk Industri (DI) er Danmarks største erhvervs- og arbejdsgiverorganisation. Vores mission er at hjælpe danske virksomheder med at vinde både i Danmark og internationalt. Med over 950 dygtige kolleger og mange eksterne samarbejdspartnere arbejder vi for at skabe de bedste vilkår for DI's medlemmer.
    • Øvrige
    • København V
    Få mere info

Statistik over udbudte jobs som øvrige i København

Herunder ser du udviklingen i udbudte øvrige 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 øvrige i København.

Se flere statistikker her:
Statistik over udbudte øvrige i København over tid

Dato Alle jobs som øvrige
17. december 2024 961
16. december 2024 991
15. december 2024 994
14. december 2024 984
13. december 2024 1008
12. december 2024 939
11. december 2024 949
10. december 2024 932
9. december 2024 936
8. december 2024 927
7. december 2024 925
6. december 2024 931
5. december 2024 918
4. december 2024 907
3. december 2024 900
2. december 2024 885
1. december 2024 915
30. november 2024 934
29. november 2024 949
28. november 2024 951
27. november 2024 941
26. november 2024 925
25. november 2024 921
24. november 2024 933
23. november 2024 933
22. november 2024 934
21. november 2024 933
20. november 2024 954
19. november 2024 936
18. november 2024 930
17. november 2024 963
Fold ud

Værd at vide når du søger job som øvrige i København

Har du også drømt om at bo og arbejde i de charmerende gader i København? Så er du ikke alene! Men drømmene bliver sjældent til virkelighed uden lidt hårdt arbejde.

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.

Find ledige jobs i Indre By

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.

Find ledige jobs i Østerbro

Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.

Find ledige jobs i Nørrebro

Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.

Find ledige jobs i Vesterbro

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.

Find ledige jobs på Amager

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

Populære søgninger

Lignende søgeresultater

Se alle populære søgninger