Home Stellen in Singen (Hohentwiel) Takeda GmbH External Supply Quality Manager, Small Molecules (f/m/d)

Stellenangebot:
External Supply Quality Manager, Small Molecules (f/m/d)

Stellenbeschreibung

Takeda beschäftigt weltweit rund 30.000 Mitarbeiter und ist in über 70 Ländern vertreten. Als größter Arzneimittelhersteller in Japan und als eines der global führenden Unternehmen seiner Branche engagiert sich Takeda seit mehr als 230 Jahren für eine bessere Gesundheitsversorgung von Menschen weltweit durch wegweisende medizinische Innovationen. Wir leben die Werte des Takeda-ism - Integrität, Fairness, Ehrlichkeit und Ausdauer - und streben danach, unsere Mission einer „Besseren Gesundheit und Schöneren Zukunft“ für alle Menschen zu verwirklichen.

Hier bedeutet jeder etwas, und auch Sie werden einen wichtigen Beitrag zu unserer inspirierenden Mission leisten. Bei Takeda wird sich Ihr Handeln positiv auf das Leben anderer Menschen auswirken - inklusive Ihr eigenes Leben.

Primary Accountabilities:

  • Responsible for the product quality performance at designated Contract Manufacturing Organisations (CMOs), to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with cGMP and Takeda Global Quality Standards
  • Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, supplier auditing, Key performance Indicators (KPI) and other Quality processes and tools as required
  • Maintain product and process
  • Supports an environment of continuous improvement
  • Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programmes for the management of Takeda outsourced material procurement, product manufacturing/packaging operations to assure the quality and compliance of Takeda and partner products

The preferred candidate has:

  • Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline and minimum of 5 years of experience in the pharmaceutical industry and/or laboratory environment
  • Experience within GMP-regulated manufacturing areas would be desired
  • Experience of cGMPs, ICH and other pertinent regulations.
  • Project Management expertise desired
  • Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner
  • Analytical Skills – ability to thoughtfully analyse a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations
  • Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management
  • Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions
  • Regulatory Understanding – broad based knowledge of domestic and general knowledge of in-ternational regulations associated with manufacturing and packaging
  • Fluent in written and spoken English

Infos zur Stelle
Arbeitszeit:
Vollzeit
Arbeitsort:
Singen (Hohentwiel)
Takeda GmbH
ZUR FIRMENPRÄSENTATION ALLE OFFENEN STELLEN
Kontakt:

Takeda GmbH
Robert-Bosch-Straße 8
78224 Singen

Ansprechpartner:
Selina Wrzeszcz

Tel: 07531 84-2108
germany.jobs@takeda.com
www.takeda.com/de-de