*Snr. Director /Director, Quality Assurance

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

København

The Director of Quality Assurance (QA) is accountable for leading and managing the day-to-day activities of the QA Operations department. The position will drive the QA organization to meet the site’s business objectives as the site increases its focus on commercial manufacturing and advancing development products through commercialization. The Director will be responsible for QA lot disposition and support of manufacturing, facilities, and QC.

KEY RESPONSIBILITIES:

  • Responsible for quality operations department and team in support of Manufacturing, Testing, and Disposition.
  • Lead and drive accountability of a diversified team of five QA departments.
  • Area consists of Quality professionals responsible for cGMP manufacturing of clinical and commercial products, including but are not limited to: raw materials/ drug substance batch record review and lot disposition, QA oversight of manufacturing activities, QA representative with customers, QA approval of product and process specific documents, QA oversight of site deviation review and approval and QA oversight of the construction, commissioning, qualification, and validation of a commercial manufacturing facility and the subsequent process validation activities.
  • Make and execute operational decisions with a strategic perspective
  • Support operations in continuous improvement initiatives by providing direction on requirements for proposed changes
  • Communicate strategic direction, quality policies/procedures and effectiveness of the Quality System at Management Reviews
  • Promote a culture of quality and accountability mindset, including continuous improvement through the establishment of KPI metrics
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
  • Prepare quality documentation, metrics, and reports by collecting, analyzing, and summarizing information and trends including failed processes, target turnaround times and disposition dates, number deviations per batch, Root Cause/CAPA activities, etc.
  • Continually work to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions
  • Demonstrate effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives
  • Provide support for internal and regulatory audits and inspections, as required
  • Other duties as may be required, according to the changing needs of the business

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to understand and apply GMP regulations as they relate to manufacturing, raw materials, testing and facility operations
  • Skilled in strategic thinking, managing through systems, 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
  • Assess performance roadblocks and develop appropriate solutions
  • Willing to have difficult conversations, meetings, and make decisions related to readiness of areas for inspection
  • Facilitate organizational change related to quality systems across multiple functions

EDUCATION/EXPERIENCE:

  • M.Sc. in chemistry or life sciences or equivalent experience
  • 10+ years of relevant experience in a biotechnology and GMP environment
  • Direct experience leading or supporting multiple functions in a pharmaceutical, biotech or a regulatory industry is requires
  • Management experience, including a demonstrated ability to effectively lead staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated

Please send your application no later than the 16th of June 2023.

Please be aware that we take in consideration only the applications send via our career page and not via email. We will process the applications as they arrive.

For further information, please contact Andreea Rata at [email protected]



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 "Produktchef", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 26.5.2023, men kan have været deaktiveret og genaktiveret igen.

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

Lignende jobs

  • Internship: Direct Procurement

    We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..
    • Produktchef
    • København Ø
    Få mere info
  • Senior Site Manager

    Produktchef søges til organisation/virksomhed i 2300 København S
    • Produktchef
    • København S
    Få mere info
  • Internship: Procurement Technology, Sustainability...

    We are a transport and logistics company providing the safe, reliable and efficient movement of people and goods - more than 12,000 colleagues, all committed to transforming our business into a gre..
    • Produktchef
    • København Ø
    Få mere info
  • Student Assistant Global Procurement

    Description As a Student Worker in the Global Procurement Team, you will primarily work with our procurement and contracts management process, and other ad hoc tasks in the team. Besides your clo..
    • Produktchef
    • København K
    Få mere info

Statistik over udbudte jobs som produktchef i København

Herunder ser du udviklingen i udbudte produktchef 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 produktchef i København.

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

Dato Alle jobs som produktchef
7. november 2024 26
6. november 2024 26
5. november 2024 26
4. november 2024 29
3. november 2024 30
2. november 2024 30
1. november 2024 30
31. oktober 2024 27
30. oktober 2024 25
29. oktober 2024 25
28. oktober 2024 24
27. oktober 2024 23
26. oktober 2024 23
25. oktober 2024 23
24. oktober 2024 22
23. oktober 2024 23
22. oktober 2024 23
21. oktober 2024 25
20. oktober 2024 29
19. oktober 2024 29
18. oktober 2024 29
17. oktober 2024 30
16. oktober 2024 32
15. oktober 2024 31
14. oktober 2024 29
13. oktober 2024 30
12. oktober 2024 30
11. oktober 2024 32
10. oktober 2024 33
9. oktober 2024 31
8. oktober 2024 31

Værd at vide når du søger job som produktchef 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