Associate Director, Device Supplier Management

Merck & Co., Inc.

Base: $129,000.00 - $203,100.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
Supplier quality management system experience
Us fda 21 cfr part 4 and part 820 knowledge
Eu mdr:2017/745 regulatory compliance expertise
The Associate Director, Device Supplier Management at Merck & Co., Inc. is responsible for leading initiatives that enhance Quality Management System (QMS) Purchasing Controls and Device Supplier Management. The role involves collaboration with cross-functional teams to ensure regulatory compliance and drive continuous improvement in supplier quality

Job Summary

  • The Associate Director will lead efforts to establish early commercialization Purchasing Controls processes and integrate Device Supplier Management activities across MDCP programs.
  • This role is accountable for ensuring compliance with MDCP current Good Manufacturing Practices (cGMPs), Global Health Authority Regulations, and driving continuous improvement in Device Supplier Quality Management.
  • 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, Device Supplier Management at Merck & Co., Inc. is responsible for leading initiatives that enhance Quality Management System (QMS) Purchasing Controls and Device Supplier Management. The role involves collaboration with cross-functional teams to ensure regulatory compliance and drive continuous improvement in supplier quality.

Salary

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

Skills & Requirements

Must-have

  • Supplier Quality Management System experience
  • US FDA 21 CFR Part 4 and Part 820 knowledge
  • EU MDR:2017/745 regulatory compliance expertise
  • ISO 13485:2016 QMS document review skills
  • Medical Device Combination Products oversight
  • GMP Auditing and Supplier Audit participation

Nice-to-have

  • Strong cross-functional collaboration abilities
  • Experience with SAP and Veeva Vault systems
  • Strategic planning for early commercialization
  • Effective written and oral communication skills
  • Ability to foster cooperation in diverse teams

Key Requirements

  • B.S. or M.S. degree in Science or Engineering
  • Minimum 8 years of relevant industry experience
  • At least 4 years in Supplier Quality Management/Purchasing Controls
  • In-depth knowledge of pharmaceutical and medical device regulations

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter