Senior QA Project Lead - GMP Compliance & Improvements

Katalyst Healthcares & Life Sciences; North Chicago (IL); On-site; USD 90,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a QA Senior Specialist to support pharmaceutical manufacturing operations. You will lead quality projects across multiple QA functions, drive process improvements, and ensure compliance with GMP and regulatory requirements.

The role partners with internal teams and third-party contractors to sustain a strong quality culture and support regulatory inspections and new market introductions.

Qualifications

• Bachelor's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or related field.
• Master's degree preferred for advanced roles.
• 5-8 years of QA/Quality Systems experience in regulated industries.
• Strong GMP, compliance, deviation/CAPA, and change control experience.
• Proven cross-functional project leadership.

Responsibilities

• Plan, coordinate, and drive QA projects across site QA functions.
• Coordinate with centralized/global quality functions for initiatives.
• Analyze data on cycle times and process activities to improve QA.
• Drive QA planning, scheduling processes, and governance.
• Support regulatory inspections and new market introductions.
• Collaborate with QA, manufacturing, regulatory, and contractors.
• Promote compliance with GMP and corporate quality standards.

Skills

GMP compliance

Quality systems

CAPA management

Change control

Risk management

Cross-functional leadership

Education

Bachelor's degree in Pharmacy or related

Master's degree preferred

Job description

Creative Solutions Services, LLC is seeking a QA Senior Specialist to support pharmaceutical manufacturing operations. You will lead quality projects across multiple QA functions, drive process improvements, and ensure compliance with GMP and regulatory requirements.

The role partners with internal teams and third-party contractors to sustain a strong quality culture and support regulatory inspections and new market introductions.