Senior Director, Quality Control Operations

vor 1 Tag

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit
Job Title: Senior Director, Quality Control Operations

CSL Seqirus is seeking a highly experienced Senior Director, Quality Control Operations to join our team. As a key member of our quality leadership team, you will be responsible for leading the development and implementation of global quality control processes and procedures to ensure compliance with regulatory requirements and corporate standards.

Key Responsibilities:
  • Develop and implement global quality control processes and procedures to ensure compliance with regulatory requirements and corporate standards.
  • Provide quality control oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
  • Ensure robust measurement and reporting tools are developed to enable accurate and timely reporting.
  • Collaborate across the CSL network to share and implement best practices.
Requirements:
  • Advanced degree (Master's) in life sciences field; PhD preferred.
  • Minimum of 12 years' experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
  • Minimum 10 years of managerial experience.
  • Experience working in a highly regulated GMP environment as it applies to laboratory and stability functions.
  • Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up.
  • Experience with testing methods and processes including raw materials testing, stability testing, and sample management.
  • LEAN experience, preferred.
About CSL Seqirus:

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

Benefits:

CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.

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