Quality Engineering Project Lead — Manufacturing & Compliance

Creative Solutions Services, LLC

Cambridge (MA)

On-site

USD 120,000 - 160,000

Full time

14 days+

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Job summary

Creative Solutions Services, LLC in Cambridge, MA, seeks a Quality Engineering Project Manager to lead a team of quality engineers supporting manufacturing quality oversight, validation, qualification, and compliance activities.

You will provide technical direction for base business operations, development, tech transfer, and market expansion projects, ensuring strategies and lifecycle activities align with Client Quality Systems and cGMP.

Qualifications

Bachelor's degree in physical or life sciences, pharmacy, or engineering.
Certified Quality Engineer or formal training in quality engineering or statistics is preferred.
8+ years in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry.
4+ years of supervisory/technical leadership.
Knowledge of physical and chemical characteristics of products and raw materials.
Familiar with statistical quality systems, electronic document management and LIMS.
Familiar with Quality policies, cGMP and regulatory requirements.
Strong people management and communication skills.
Bachelor's, Master's or PhD in Life Science or Engineering is highly desired.
Demonstrated strategic vision and cross-functional collaboration.

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 Client 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.