QA Lead - External Partners & GMP Oversight

Merck; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid holidays

Job summary

Merck in Rahway, NJ seeks an experienced Quality Assurance leader to oversee external contractors performing GMP activities for clinical supplies. You will act as SME for contractor quality events, audits, and change controls, coordinating with R&D, QA disposition, and procurement.

Requires a BS in a scientific field and 10+ years in pharma; 8+ years with advanced degree. Strong leadership, regulatory knowledge, and travel up to 25% are expected.

Qualifications

• Bachelor’s degree in a scientific or engineering field is required.
• Minimum 10 years of pharma industry experience; or 8+ years with an advanced degree.
• Strong knowledge of GMP, R&D processes and external contractor management.

Responsibilities

• Lead quality oversight for external entities/CMOs and third-party vendors.
• Drive investigations, CAPs, change controls and audits related to contractors.
• Coordinate with QA disposition, procurement and development teams on compliance objectives.
• Lead cross-functional teams in contractor quality events and data integrity reviews.

Skills

Audit Management

Batch Releases

Compliance Investigations

Deviation Management

GMP

Project Leadership

Quality Oversight

Quality Risk Management

Quality Systems

Regulatory Compliance

Education

Bachelor’s Degree in Pharmacy, Biology, Engineering, Chemistry or related field

Job description

Merck in Rahway, NJ seeks an experienced Quality Assurance leader to oversee external contractors performing GMP activities for clinical supplies. You will act as SME for contractor quality events, audits, and change controls, coordinating with R&D, QA disposition, and procurement.

Requires a BS in a scientific field and 10+ years in pharma; 8+ years with advanced degree. Strong leadership, regulatory knowledge, and travel up to 25% are expected.