Senior QA Specialist — Quality & Compliance Lead

Novo Nordisk, Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

The successful candidate has a Bachelor’s degree in a relevant field and 1–2 years of pharmaceutical quality experience, strong analytical skills, and proficiency with QMS and document management.

Qualifications

• Attention to Detail with controlled documents and change control.
• Clear communication to stakeholders about quality requirements.
• Cross-functional collaboration across QA, Regulatory, and Supply Chain.
• Ability to analyze data and identify trends for quality improvement.
• Proficiency with standard office tools and QMS systems.
• Quick learning of new processes, tools, and regulatory/QMS requirements.

Responsibilities

• Support QMS/SOP management including document control activities and training administration.
• Support deviation management and CAPA execution: documentation support, track actions to closure.
• Assist in vendor/distributor quality oversight, follow-up of quality issues.
• Perform quality review of batch documentation and release documentation within scope.
• Handle product quality complaints with data review and timely tracking.
• Participate in internal audits and Health Authority inspection readiness activities.
• Collaborate with cross-functional teams to implement risk mitigation and ensure compliance.
• Maintain accurate QA records and contribute to quality metrics.

Skills

Attention to Detail

Communication

Collaboration

Analytical Thinking

Computer Literacy

Learning Agility

Education

Bachelor's degree in Pharmacy/ Life Sciences/ Chemistry/ Engineering

Job description

The successful candidate has a Bachelor’s degree in a relevant field and 1–2 years of pharmaceutical quality experience, strong analytical skills, and proficiency with QMS and document management.