Quality Assurance Manager

2 days ago


Thousand Oaks, California, United States Takeda Pharmaceutical Company Ltd Full time

About the Role:

As a Quality Assurance Manager at Takeda Pharmaceutical Company Ltd, you will play a critical role in ensuring the quality and compliance of our manufacturing operations. You will lead a team of quality professionals in detecting and resolving compliance issues in real-time, providing essential quality oversight and support during manufacturing activities. Your expertise will be essential in ensuring the safety and reliability of our products.

Key Responsibilities:

  • Lead a team of quality professionals in supporting drug substance and finishing manufacturing areas.
  • Coach and provide feedback to team members to improve performance.
  • Oversee recruitment, training, and talent development for the quality team.
  • Ensure compliance with quality goals, regulatory requirements, and industry best practices.
  • Manage resources to meet supply chain demands and implement lean concepts to improve cycle times.
  • Work with manufacturing management to ensure CGMP compliance and quality systems.
  • Provide direction in the event of manufacturing incidents that may affect quality or compliance.
  • Ensure compliance with current regulatory or product license requirements and CGMPs.
  • Support the Thousand Oaks facility during external and regulatory inspections.

Requirements:

  • Bachelor's degree in sciences or engineering preferred.
  • Minimum 10 years' experience in a quality operations position in a biotechnology, biologics, or pharmaceutical manufacturing facility.
  • Minimum 5 years of leadership, supervisory, or management experience preferred.
  • Substantial knowledge of industry best practices, trends, and an understanding of the Biopharmaceutical business.
  • Experience in microbial control strategies, cleanroom cleaning, sanitization, material transfer methods, and environmental monitoring.

What We Offer:

  • Competitive salary range: $108,500.00 - $170,500.00.
  • Short-term and long-term incentives.
  • Medical, dental, vision insurance.
  • 401(k) plan and company match.
  • Short-term and long-term disability coverage.
  • Basic life insurance.
  • Tuition reimbursement program.
  • Paid volunteer time off.
  • Company holidays.
  • Well-being benefits.

Equal Employment Opportunity:

Takeda is proud to be an equal opportunity employer and welcomes applications from diverse candidates.



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