Senior Shop Floor QA Lead, 2nd Shift (Pharma)

MSD; North East; On-site; GBP 71,000 - 112,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid holidays

Vacation

Sick days

Job summary

MSD in Durham, NC, USA is seeking a Quality Assurance Manager to lead the Shop Floor Quality Assurance on the 2nd shift. You will oversee end‑to‑end QA support for production, aseptic processes, and the batch review lifecycle, ensuring compliance with cGMP and the company's QMS.

Ideal candidates have a strong background in pharmaceutical manufacturing, people leadership, and experience with quality risk management and deviation handling.

Qualifications

• Bachelor’s degree in a life science or engineering field with pharma industry exposure.
• Master’s degree preferred with several years in regulated environments.
• Experience in aseptic manufacturing or clean rooms is required.

Responsibilities

• Manage Shop Floor Quality Assurance on second shift and lead the QA team.
• Provide end-to-end QA support for production, drug substance and product.
• Ensure cGMP compliance and adherence to QA policies and QMS.
• Support deviation management, investigations and CAPA activities.
• Collaborate with Operations and Technical Operations for readiness and events.

Skills

Aseptic manufacturing

People management

cGMP knowledge

Decision making

Problem solving

Communication

Fast-paced environments

Quality systems familiarity

Quality auditing

Education

Bachelor’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline

Master’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline

Tools

Kneat

Veeva Vault

MEDS

SAP

Electronic Batch Records (MES)

Trackwise

GLIMS

Job description

MSD in Durham, NC, USA is seeking a Quality Assurance Manager to lead the Shop Floor Quality Assurance on the 2nd shift. You will oversee end‑to‑end QA support for production, aseptic processes, and the batch review lifecycle, ensuring compliance with cGMP and the company's QMS.

Ideal candidates have a strong background in pharmaceutical manufacturing, people leadership, and experience with quality risk management and deviation handling.