Home Stellen in Singen (Hohentwiel) Takeda GmbH Head of Quality Compliance (f/m/d)

Head of Quality Compliance (f/m/d)


Your Accountabilities

  • 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 related field and can look back on at least 10 Years experience in the pharmaceutical / biopharma industry including commercial GMP operations, preferrable in Quality Assurance
  • You already acted in a role as Lead Auditor or you possess wide knowledge an experience in various kinds of international cGMP Inspections  (EMA, CDER/ CBER etc)
  • You have a broad overview over all relvant national and international pharma- / biopharma directives and guidelines, especially 21 CFR 210/211, 600/601/610, EU GMP Guideline, WHO GMP, Quality Standards and know their requirements. Ideally, you possess experience in implementig these requirement in a meaningful, solution –oriented way which bring the organization forward
  • Ideally you already lead a team: Your leadership creates an environment that inspires and enables people to focus on priorities
  • You know your MS Office tools and are acquainted with electronic quality management systems
  • Your are fluent in German and English
  • You are an effective communicator that creates clarity, fosters alignment and meets commitments

Infos zur Stelle
Singen (Hohentwiel)
Takeda GmbH

Takeda GmbH
Robert-Bosch-Straße 8
78224 Singen

Selina Wrzeszcz

Tel: 07531 84-5410