Global Supplier Quality Leader

Merck Gruppe - MSD Sharp & Dohme; Rahway (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme seeks an Associate Director, Supplier Quality Assurance to provide strategic oversight of global API suppliers, ensuring cGMP compliance and patient safety. This role leads cross-functional teams in a virtual matrixed environment, applying advanced regulatory knowledge and risk-guided guidance to sustain supplier performance.

You will mentor teams, manage Quality Agreements, and coordinate regulatory interactions while driving CAPA, change controls, and audits

Qualifications

• Bachelor’s degree in a scientific/engineering field as stated.
• 8+ years in GMP-regulated environments with QA/QC experience.
• Strong knowledge of EU, FDA, ICH guidelines and Annex 1 where applicable.
• Hands-on experience with quality systems and CAPA processes.

Responsibilities

• Serve as primary quality liaison for strategic API suppliers and ensure GMP compliance.
• Maintain Quality Agreements and coordinate regulatory impact assessments.
• Lead on-site/remote supplier audits and drive CAPA with effectiveness verification.
• Strengthen QMS elements: change control, deviations, investigations, document control, training, audits.
• Oversee technology transfers and process validation support.
• Drive inspection readiness and represent the company in regulatory interactions.

Skills

GMP compliance

Quality Assurance

Cross-functional collaboration

Supplier quality

Root-cause analysis

Auditing

Regulatory knowledge

Leadership in matrixed orgs

Education

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or related field

Tools

QMS/LIMS/TrackWise

Excel data analysis

Job description

Merck Gruppe - MSD Sharp & Dohme seeks an Associate Director, Supplier Quality Assurance to provide strategic oversight of global API suppliers, ensuring cGMP compliance and patient safety. This role leads cross-functional teams in a virtual matrixed environment, applying advanced regulatory knowledge and risk-guided guidance to sustain supplier performance.

You will mentor teams, manage Quality Agreements, and coordinate regulatory interactions while driving CAPA, change controls, and audits