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Head of Quality Compliance (f/m/d)

Singen (Hohentwiel), Germany

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Head of Quality Compliance (f/m/d)

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Job ID R0016419 Date posted 01/24/2020 Location Singen (Hohentwiel), Germany

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Job Description

YourAccountabilities

  • You safeguard the site’s positive regulatory profile (RP Tübingen, FDA, WHO, Russia, ANVISA) for small molecules and vaccines manufacturing (in launch)
  • You are a team leader that inspires, enables and steers on equal bases: you lead your own team of four Compliance managers and 16 specialists 
  • You take responsibility to continuously improve the site’s integrity with International cGMP &  Takeda Quality Standards 
  • You perform product monitoring (APR, PQR), QMS monitoring & oversee risk management processes.
  • You are the primary contact for our regulatory bodies and our customers, and you represent Takeda to reinforce Takeda's  reputation
  • You supervise regulatory submissions
  • You manage Inspections & Audits representing Takeda’s quality management system and ensure successful outcome
  • You manage, oversee and lead quality incident processes within crossfunctional teams of specialists

Your Profile

  • You hold a University degree in Natural Science or a relatedfield and canlook back on at least 10 Yearsexperience in thepharmaceutical / biopharmaindustryincluding commercial GMP operations, preferrable in Quality Assurance 
  • Youalreadyacted in a roleas Lead Auditor oryoupossesswideknowledge an experience in variouskindsof international cGMP Inspections  (EMA, CDER/ CBER etc)
  • Youhave a broadoverviewover all relvant national and international pharma- / biopharmadirectives and guidelines, especially 21 CFR 210/211, 600/601/610, EU GMP Guideline, WHO GMP, Quality Standards and knowtheirrequirements. Ideally, youpossessexperience in implementigtheserequirement in a meaningful, solutionorientedwaywhich bring theorganizationforward
  • Ideallyyoualreadylead a team: Yourleadershipcreates an environmentthatinspires and enablespeopletofocus on priorities
  • Youknowyour MS Office tools and areacquaintedwith electronic qualitymanagementsystems
  • Yourarefluent in German and English
  • Youare an effectivecommunicatorthatcreatesclarity, fostersalignment and meetscommitments

Takeda GmbH

Human Resources Germany

Robert-Bosch-Straße 8, 78224 Singen
Tel.: +49 7531-84 2108

germany.jobs@takeda.com
http://www.takeda.com/de-de/

Locations

Singen, Germany

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0016419

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