Senior QA Lead, Biologics — GMP Compliance & Release

Merck; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck in Rahway, NJ is seeking a Senior Specialist, Quality Assurance BDQR to provide QA oversight and technical support for analytical and process development activities supporting large molecule programs.

You will partner with stakeholders to enable compliant execution, manage deviations, CAPA, change controls, and audit support while maintaining cGMP compliance and industry best practices. Hybrid work arrangement available.

Qualifications

• Minimum of 5 years in Pharmaceutical/Biotechnology with a BS, or 3+ years with an advanced degree.
• Experience in Biologics Quality, Biologics Manufacturing, and/or related functions at pilot or commercial scale.
• Strong knowledge of current Good Manufacturing Practice (cGMP).
• Understanding of health authority regulations and GMPs in an R&D environment.
• Demonstrated ability to manage projects and priorities to meet deliverables and timelines.
• Excellent interpersonal, verbal and written communication skills.

Responsibilities

• Provide Quality oversight and execute GMP/GxP QA activities for manufacturing and testing, including batch documentation review.
• Oversee biologics clinical space to identify compliance risks and support compliant execution.
• Partner cross‑functionally to enable compliant start‑up and GMP activities.
• Support quality-by-design through quality systems, procedures and documentation controls.
• Build partnerships to provide QA guidance and timely decision making for deviations, change controls and audits.
• Contribute to training, audit readiness and quality performance monitoring.
• Stay informed on GMP requirements and industry trends affecting biologics, analytics and manufacturing.
• Ensure SOPs reflect current regulations and update as needed.
• Review and approve GMP documentation for regulatory filings, clinical supply and tech transfer.
• Act as QA representative for internal/external manufacturing and testing programs.

Skills

Audits

CAPA

Deviation Mgmt

GMP Auditing

Manufacturing

Operational Compliance

Operational Quality

QA Processes

QA Systems

Quality Risk Mgmt

Education

Bachelor’s degree in science/engineering or related field

Tools

SAP

Automation

Electronic Batch Records

Job description

Merck in Rahway, NJ is seeking a Senior Specialist, Quality Assurance BDQR to provide QA oversight and technical support for analytical and process development activities supporting large molecule programs.

You will partner with stakeholders to enable compliant execution, manage deviations, CAPA, change controls, and audit support while maintaining cGMP compliance and industry best practices. Hybrid work arrangement available.