Senior Quality Assurance Specialist - Pharma Process Leader

Katalyst CRO; North Chicago (IL); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a QA Senior Specialist to provide quality assurance support for pharmaceutical manufacturing operations, ensuring GMP compliance and adherence to corporate standards.

The role will lead and coordinate quality projects across multiple QA functions, drive process improvements, monitor KPIs, and support regulatory inspections and product registrations with internal stakeholders and Third-Party Contractors (TPCs).

Qualifications

• Must have strong GMP knowledge and exposure to QA systems.
• Experience leading cross-functional quality and continuous improvement projects.
• Familiarity with regulatory inspections and product registrations.

Responsibilities

• Plan, coordinate, and drive QA projects across multiple site QA functions.
• Coordinate with centralized/global quality functions to support initiatives.
• Analyze and maintain data related to QA activities to identify optimization opportunities.
• Drive QA planning and scheduling process improvements.
• Ensure visual management tools monitor critical quality processes.
• Analyze metrics and report trends, risks, and opportunities.
• Identify risks and implement mitigation plans and fallback strategies.
• Lead development of Project Charters and governance.
• Lead or coordinate regulatory inspections and product registrations.
• Collaborate with QA, manufacturing, regulatory, and engineering teams.
• Maintain communication with Third-Party Contractors and their Quality orgs.
• Promote continuous improvement and sustained GMP compliance.
• Support quality activities across the product lifecycle.

Skills

QA project coordination

GMP knowledge

Quality systems

Data analysis

Risk management

Cross-functional collaboration

Regulatory inspections

Project governance

Education

Pharmacy

Pharmaceutical Sciences

Chemistry

Biology

Microbiology

Biotechnology

Engineering

Related field

Tools

QMS software

Deviation/CAPA tooling

Change control systems

Quality metrics dashboards

Job description

Katalyst CRO is seeking a QA Senior Specialist to provide quality assurance support for pharmaceutical manufacturing operations, ensuring GMP compliance and adherence to corporate standards.

The role will lead and coordinate quality projects across multiple QA functions, drive process improvements, monitor KPIs, and support regulatory inspections and product registrations with internal stakeholders and Third-Party Contractors (TPCs).