Associate Director, Drug Product QA - Global Compliance

MSD; Wilmington (DE); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. is seeking an Associate Director for Drug Product Quality Assurance to establish a Quality structure for sterile DP operations in Delaware.

The role emphasizes cGMP compliance, regulatory requirements, and building a robust QA culture to enable unconstrained supply of breakthrough medicines. The successful candidate will lead a DP QA team, drive investigations, CAPAs, tech transfers, and regulatory readiness, while partnering with global teams to ensure quality and compliance

Qualifications

• Requires 10+ years in Quality Control/Quality Assurance or related operations.
• Experience with cGMPs, regulatory guidelines (US/EU).
• Strong leadership and team-management skills.

Responsibilities

• Lead the sterile Drug Product QA team.
• Ensure GMP compliance for biologics DP manufacturing.
• Review and approve GMP documentation.
• Investigate deviations and drive CAPAs.
• Support regulatory submissions and inspections.
• Manage batch record review and change controls.
• Provide audit support and regulatory interaction.
• Lead continuous improvement in Quality Management Systems.

Skills

GMP knowledge

Root cause analysis

CAPA

Regulatory inspections

Tech transfer

Process validation

Communication

Analytical thinking

Multi-tasking

Problem solving

Education

Bachelor's degree in Chemistry/Biology/Microbiology or related

Tools

DMAIC

Lean QA

5S

Job description

Merck & Co., Inc. is seeking an Associate Director for Drug Product Quality Assurance to establish a Quality structure for sterile DP operations in Delaware.

The role emphasizes cGMP compliance, regulatory requirements, and building a robust QA culture to enable unconstrained supply of breakthrough medicines. The successful candidate will lead a DP QA team, drive investigations, CAPAs, tech transfers, and regulatory readiness, while partnering with global teams to ensure quality and compliance