Head of Quality Compliance (m/f/d)

  • 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
  • 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

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Takeda GmbH
78224 Singen