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← Obsidian Therapeutics

Quality Systems Manager/Senior Manager

Obsidian Therapeutics
Location
Bedford, MA (HYBRID)
Posted
16 days ago
Department
Quality Assurance
What they actually want (must-haves)
  • Bachelor's degree
  • 6+ years of experience in QA within clinical late stage biopharmaceutical environments
  • 3+ years of direct process ownership or administration of quality systems, including change control
  • Successful experience leading or playing a significant role in implementation of an eQMS
  • Management of systems such as Veeva, MasterControl, TrackWise, or equivalent platforms
  • Strong working knowledge of FDA, EU GMP, ICH, and applicable GxP regulations
Nice to have
  • Experience leading full eQMS implementation as business process owner
  • Strong project management and organizational skills
  • Ability to influence cross-functional teams without direct authority
What the job really is

The Quality Systems Manager/Senior Manager at Obsidian Therapeutics will oversee the Quality Management System (QMS), focusing on processes such as Change Control, Product Complaints, and CAPA. This role involves ensuring compliance with regulatory standards, managing documentation, and leading the implementation of an electronic Quality Management System (eQMS). The position requires collaboration with various departments to optimize quality processes and support clinical development efforts.

Benefits
  • Competitive salary
  • Annual incentive bonus
  • Long-term incentives in the form of employee stock options
  • Comprehensive medical, dental, and vision coverage
  • Company contributions to health savings and retirement accounts
  • Ample paid time off
Things to weigh
  • Hybrid role based in Bedford, MA
  • No specific mention of remote work flexibility
  • Salary range provided, but actual salary may vary based on multiple factors
Job score3.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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