Associate Director, Quality Systems & Compliance (design Controls)

Merck & Co., Inc.

Base: $129,000.00 - $203,100.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
10 years pharmaceutical or medical device experience
Knowledge of iso 13485 and fda 21 cfr part 820
Experience with design controls and qms document management
The Associate Director, Quality Systems & Compliance at Merck & Co., Inc. is a key role responsible for overseeing quality management systems related to design controls within the manufacturing division. The position focuses on continuous improvement, compliance with global health regulations, and collaboration with cross-functional teams

Job Summary

  • The Associate Director will support the Manufacturing Division's Quality Management System Topic 3.3 regarding Design Controls and lead continuous improvement initiatives.
  • This role requires deep knowledge of US FDA 21 CFR Part 820, EU MDR, and ISO 13485 to ensure site and function compliance with global requirements.
  • The successful candidate will be eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 85

The Associate Director, Quality Systems & Compliance at Merck & Co., Inc. is a key role responsible for overseeing quality management systems related to design controls within the manufacturing division. The position focuses on continuous improvement, compliance with global health regulations, and collaboration with cross-functional teams.

Salary

Base: $129,000.00 - $203,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 10 years pharmaceutical or medical device experience
  • Knowledge of ISO 13485 and FDA 21 CFR Part 820
  • Experience with Design Controls and QMS document management
  • Ability to drive continuous improvement in global teams
  • Strong knowledge of IEC 62304 software life-cycle processes

Nice-to-have

  • Experience with EU MDR 2017/745 regulations
  • Background in combination products
  • Cross-cultural team collaboration skills
  • Ability to foster a culture of continuous improvement
  • Experience with CAPA implementation and audit responses

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
  • No visa sponsorship available

Work Rights

Not specified

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