Quality Engineering Lead: Manufacturing & Compliance

Creative Solutions Services, LLC; Detroit (MI); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Engineering Project Manager to lead a team of quality engineers supporting manufacturing processes and quality oversight across base operations. The role drives validation, qualification, and risk-based compliance decisions, manages resources and budgets, and partners with cross-functional groups to ensure product quality and regulatory readiness.

Strong leadership, communication skills, and a solid background in cgmp and quality systems are

Qualifications

• Minimum Bachelor's degree in Physical or Life Sciences, Pharmacy, or Engineering.
• Certified Quality Engineer or formal training in quality engineering is preferred.
• 8+ years in Manufacturing, QA, QC, R&D in pharma, biologics, device or chemical industries.
• 4+ years of supervisory/technical leadership experience.
• Familiar with cgmp, regulatory requirements, and statistical quality systems.

Responsibilities

• Leads and develops a team of quality engineers supporting manufacturing processes and compliance activities.
• Provides functional leadership for quality engineering across manufacturing processes, equipment, utilities, facilities, and systems.
• Directs quality engineering matters related to base business operations, development, tech transfer, and market expansion projects.
• Ensures validation and qualification strategies, protocols, and lifecycle activities meet Client Quality Systems and cgmp requirements.
• Addresses quality and compliance gaps and drives risk-based actions.

Skills

Quality management

Leadership

Communication

Quality systems

Statistical quality

Education

Bachelor's degree in Physical or Life Sciences, Pharmacy, or Engineering

Master's or PhD in Life Science or Engineering

Certified Quality Engineer

Job description

Creative Solutions Services, LLC is seeking a Quality Engineering Project Manager to lead a team of quality engineers supporting manufacturing processes and quality oversight across base operations. The role drives validation, qualification, and risk-based compliance decisions, manages resources and budgets, and partners with cross-functional groups to ensure product quality and regulatory readiness.

Strong leadership, communication skills, and a solid background in cgmp and quality systems are