Associate Director, Quality Systems & Compliance (Design Controls)
Merck
July 01, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Brief Description of Position
Associate Director Quality Systems & Compliance for Device Quality & Regulatory supporting Manufacturing Division QMS Topic 3.3 (MDCP Design Controls). Leads continuous improvement initiatives and QMS topic lifecycle management.
Responsibilities / Primary Activities (including, but not limited to)
- Collaborate with cross-functional teams to identify improvement opportunities and address internal/external audit observations.
- Oversight and lifecycle management of Topic 3.3 procedures in the QMS, including document change control/implementation and maintenance of the Global Training Plan/courses.
- Act as subject matter expert; align with global Topic 3.3 requirements and ensure site/function compliance.
- Attend Topic 3.3 CoP, QMS Chapter 3, MDCP Site Communication, and Document Control Technical Committee meetings.
- Drive/monitor compliance and continuous improvement; report topic health (implementation, effectiveness, trends).
- Support identification/resolution/escalation of issues; support observation responses and timely CAPA implementation.
Education Requirements
- B.S. and/or M.S. in a Science or Engineering discipline with 10+ years’ in-depth experience in pharmaceutical/medical devices/combination products.
Required / Preferred Qualifications
- 3 years relevant experience in Regulatory CMC, Quality, development, manufacturing, testing, or licensure of pharmaceutical/medical device/combination products.
- Preferred: experience assessing US FDA 21 CFR Part 4 & Part 820, EU MDR 2017/745, ISO 13485:2016, ISO 14971:2019; IEC 62304.
- Knowledge of applicable regulations; working knowledge of medical device lifecycle activities; experience authoring/reviewing/approving QMS documents.
Skills
- Design controls, GMP/cGMP compliance, QMS, risk management, driving continuous improvement, global collaboration.
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate/sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Associate Director Quality Systems & Compliance for Device Quality & Regulatory supporting Manufacturing Division QMS Topic 3.3 (MDCP Design Controls). Leads continuous improvement initiatives and QMS topic lifecycle management.
Responsibilities / Primary Activities (including, but not limited to)
- Collaborate with cross-functional teams to identify improvement opportunities and address internal/external audit observations.
- Oversight and lifecycle management of Topic 3.3 procedures in the QMS, including document change control/implementation and maintenance of the Global Training Plan/courses.
- Act as subject matter expert; align with global Topic 3.3 requirements and ensure site/function compliance.
- Attend Topic 3.3 CoP, QMS Chapter 3, MDCP Site Communication, and Document Control Technical Committee meetings.
- Drive/monitor compliance and continuous improvement; report topic health (implementation, effectiveness, trends).
- Support identification/resolution/escalation of issues; support observation responses and timely CAPA implementation.
Education Requirements
- B.S. and/or M.S. in a Science or Engineering discipline with 10+ years’ in-depth experience in pharmaceutical/medical devices/combination products.
Required / Preferred Qualifications
- 3 years relevant experience in Regulatory CMC, Quality, development, manufacturing, testing, or licensure of pharmaceutical/medical device/combination products.
- Preferred: experience assessing US FDA 21 CFR Part 4 & Part 820, EU MDR 2017/745, ISO 13485:2016, ISO 14971:2019; IEC 62304.
- Knowledge of applicable regulations; working knowledge of medical device lifecycle activities; experience authoring/reviewing/approving QMS documents.
Skills
- Design controls, GMP/cGMP compliance, QMS, risk management, driving continuous improvement, global collaboration.
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate/sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.