Quality Engineering Project Manager

job summary:

• The Quality Engineering Project Manager provides leadership, direction, and technical oversight for the Quality Engineering team within Operations. This role leads quality engineers who support manufacturing processes and provide quality engineering expertise for product, process, equipment, utility, and facility-related activities. The position ensures effective implementation of Company Quality Systems and supports validation, qualification, and risk-based compliance decisions across base business and development or market expansion initiatives. The Quality Engineering Project Manager also manages functional resources and budget while maintaining strong quality, compliance, and operational performance.

location: Waukegan, Illinois
job type: Contract
salary: $55.00 - 69.15 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Leads and develops a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and compliance activities.
• Provides functional leadership for quality engineering activities 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 are executed in accordance with Company Quality Systems, cGMP requirements, and applicable regulations.
• Reviews quality and compliance gaps related to manufacturing processes, equipment, utilities, systems, and change controls, and drives appropriate risk-based actions.
• Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementation of new and existing processes.
• Guides risk management activities, including assessments, mitigation planning, and application of quality risk management principles.
• Oversees or supports qualification and validation activities for equipment, processes, cleaning, utilities, computerized systems, and methods, as applicable.
• Ensures quality engineering issues impacting product quality, process robustness, and regulatory compliance are identified, escalated, and resolved.
• Communicates quality engineering status, key risks, trends, and recommendations to management and executive stakeholders, and manages functional resources and budget to support efficient execution.

 
qualifications:

• Minimum Bachelor's Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering
• Certified Quality Engineer or formal training in quality engineering or statistics is preferred
• 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
• 4+ years of supervisory/technical leadership experience
• Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
• Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
• Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
• Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
• Strong communication Skills, both oral and written

Preferred:

• Bachelor's, Master's or PhD in a Life Science or Engineering is Highly Desired.
• Demonstrated strategic vision and leadership in building and sustaining a high-performing team responsible for managing base business priorities, site-related projects, compliance remediation activities, and global project deliverables is Highly Desired.
• Strong cross-functional collaboration and negotiation skills, with the ability to influence stakeholders, align priorities, and drive effective outcomes across complex and diverse functional teams is Highly Desired.

#LI-CV1

skills: Project Management, MS-Project, Quality Assurance (QA), Quality Control (QC)




Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.




Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).




This posting is open for thirty (30) days.