Quality Engineering Project Leader — Manufacturing & Compliance

Creative Solutions Services, LLC; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Quality Engineering Project Manager to provide leadership for the Quality Engineering team within Operations, overseeing validation, qualification, and compliance activities across manufacturing processes and facilities.

You will manage cross-functional projects, drive risk-based decisions, and ensure adherence to quality systems and regulatory requirements in base business and development initiatives.

Qualifications

• Bachelor's degree in physical or life sciences, pharmacy, or engineering.
• Certified Quality Engineer or formal training in quality engineering or statistics.
• 8+ years in manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry.
• 4+ years of supervisory/technical leadership experience.
• Must have basic understanding of physical and chemical characteristics of products and raw materials.
• Familiar with statistical quality systems, electronic document management and laboratory information management.
• Familiar with Quality policies, cGMP and regulatory requirements.
• Effective people management and communication skills to supervise and collaborate.
• Strong communication skills (oral and written).
• Bachelor's, Master's or PhD in Life Science or Engineering is highly desired.
• Strategic vision and leadership for managing base business priorities and cross-functional projects.
• Strong cross-functional negotiation skills to influence stakeholders.

Responsibilities

• Leads and develops a team of quality engineers supporting manufacturing quality oversight, validation, qualification, and compliance activities.
• Provides functional leadership across manufacturing processes, equipment, utilities, facilities, and associated systems.
• Provides technical direction for quality engineering matters related to base business operations, development, tech transfer, and market expansion projects.
• Ensures validation and qualification strategies, protocols, reports, and lifecycle activities align with Client Quality Systems and cGMP requirements.
• Reviews quality and compliance gaps and drives risk-based actions.
• Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementations.
• Guides risk management activities including assessments and mitigation planning.
• Oversees qualification and validation for equipment, processes, cleaning, utilities, computerized systems, and methods.
• Ensures quality issues impacting product quality and regulatory compliance are addressed.
• Communicates status and risks to management and executive stakeholders; manages resources and budget.

Skills

Quality engineering leadership

Communication skills

People management

Cross-functional collaboration

Leadership

Education

Bachelor's degree in physical or life sciences, pharmacy, or engineering

Master's or PhD in life science or engineering

Tools

LIMS

Electronic Document Management

Statistical quality systems

Job description

Creative Solutions Services, LLC seeks a Quality Engineering Project Manager to provide leadership for the Quality Engineering team within Operations, overseeing validation, qualification, and compliance activities across manufacturing processes and facilities.

You will manage cross-functional projects, drive risk-based decisions, and ensure adherence to quality systems and regulatory requirements in base business and development initiatives.