Associate Director, Quality Systems & Compliance (design Controls)

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Base: $129,000.00 - $203,100.00; bonus/equity: ann...
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10+ years pharmaceutical or medical device experience
Deep knowledge of iso 13485 and fda regulations
Experience with quality management system document authoring
** The Associate Director, Quality Systems & Compliance position at Merck focuses on overseeing Design Controls within the Manufacturing Division's Quality Management System. The role requires extensive experience in regulatory compliance related to medical devices, and the successful candidate will lead continuous improvement initiatives while collaborating with cross-functional teams. **

Job Summary

  • The Associate Director will support the Manufacturing Division's QMS Topic 3.3 Design Controls and lead continuous improvement initiatives across all business processes.
  • This role requires oversight of the entire lifecycle management of procedures, including document change control and maintenance of the Global Training Plan.
  • Candidates must possess strong organizational skills and the ability to effectively communicate and collaborate within diverse global teams to ensure compliance with cGMPs and ISO standards.

Matching Summary

Match Score: 75

** The Associate Director, Quality Systems & Compliance position at Merck focuses on overseeing Design Controls within the Manufacturing Division's Quality Management System. The role requires extensive experience in regulatory compliance related to medical devices, and the successful candidate will lead continuous improvement initiatives while collaborating with cross-functional teams. **

Salary

Base: $129,000.00 - $203,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Comprehensive package including medical, dental, vision, 401(k), and paid time off

Skills & Requirements

Must-have

  • 10+ years pharmaceutical or medical device experience
  • Deep knowledge of ISO 13485 and FDA regulations
  • Experience with Quality Management System document authoring
  • Expertise in Design Controls lifecycle management
  • Strong background in CAPA implementation and audit response

Nice-to-have

  • Knowledge of IEC 62304 software life-cycle processes
  • Experience with EU MDR 2017/745 requirements
  • Ability to foster cross-cultural team collaboration
  • Proven track record in driving continuous improvement initiatives
  • Experience attending Community of Practice meetings

Key Requirements

  • B.S. or M.S. degree in Science or Engineering
  • Minimum 10 years of relevant industry experience
  • 3 years specific experience in Regulatory CMC or Quality
  • Working knowledge of US FDA 21 CFR Part 4 and Part 820

Work Rights

Not specified

Tailored Resume

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