Associate Director, Quality Systems & Compliance (design Controls)

539

Base: $129,000.00 - $203,100.00; bonus/equity: ann...
Hybrid (3 days on-site, 1 remote)
10 years experience in pharmaceutical or medical devices
Knowledge of iso 13485:2016 and iso 14971:2019
Expertise in us fda 21 cfr part 820 regulations
The Associate Director, Quality Systems & Compliance position at Merck involves overseeing the Quality Management System (QMS) for design controls in the manufacturing division, with a focus on continuous improvement and compliance with regulatory standards. The role requires significant experience in the pharmaceutical or medical device sectors, emphasizing collaboration with cross-functional teams and effective communication

Job Summary

  • The Associate Director will oversee lifecycle management of procedures related to MDCP Design Controls within the Quality Management System.
  • Candidates must possess in-depth knowledge of regulatory requirements including EU MDR:2017/745 and cGMPs to ensure site compliance.
  • The role offers a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility.

Matching Summary

Match Score: 85

The Associate Director, Quality Systems & Compliance position at Merck involves overseeing the Quality Management System (QMS) for design controls in the manufacturing division, with a focus on continuous improvement and compliance with regulatory standards. The role requires significant experience in the pharmaceutical or medical device sectors, emphasizing collaboration with cross-functional teams and effective communication.

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

Skills & Requirements

Must-have

  • 10 years experience in pharmaceutical or medical devices
  • Knowledge of ISO 13485:2016 and ISO 14971:2019
  • Expertise in US FDA 21 CFR Part 820 regulations
  • Experience with Design Controls (MDCP Topic 3.3)
  • Ability to author and approve Quality Management System documents

Nice-to-have

  • Strong cross-cultural team collaboration skills
  • Experience with IEC 62304 software life-cycle processes
  • Proven ability to drive continuous improvement culture
  • Effective communication for global stakeholder alignment

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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