Quality Assurance Engineering Lead – Global GMP Programs

Veg Group; Northern (KY); On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Assurance Engineering Lead to oversee global engineering programs, ensuring GMP compliance, contamination control, and product quality across biologics, API, aseptic manufacturing and medical devices.

You will act as the primary QA representative on cross-functional teams and drive risk-based decisions. Responsibilities include governance of QA activities from design reviews to qualification, leading contamination control strategies, and

Qualifications

• Bachelor/Masters in Engineering, or Science related discipline with relevant experience within API, biomanufacturing, aseptic manufacturing, terminal sterilization, medical device and QC/microbiology laboratories.
• 8+ years’ experience in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Knowledge of the principles and concepts applicable to aseptic manufacturing, terminal sterilization, API and biologics (DS/DP), and GMP requirements.
• Knowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirements.
• Knowledge and experience with risk-based qualification and quality risk management.

Responsibilities

• Provide quality assurance governance and oversight for global engineering programs including biologics, API, aseptic manufacturing, terminally sterilized products, medical devices and laboratories.
• Provide QA guidance at facility, utility and equipment design reviews and GMP reviews from concept design through detail design, ensuring risks are mitigated.
• Lead contamination control risk assessments with cross-functional teams to identify, evaluate and mitigate GMP risks by design.
• Lead development of the initial contamination control strategy for global engineering programs at sites.
• Make key decisions regarding GMP and quality requirements for facility, utility and equipment designs and report regulatory risks and quality risks to the project risk register.
• Participate in system risk assessments and review qualification documents in compliance with risk-based qualification requirements.
• Establish relationships with site quality teams and cross-functional members to achieve quality deliverables including GMP/quality risk mitigation.
• Communicate effectively, both verbally and in writing, with stakeholders and management.

Skills

Quality Assurance

Communication

Project management

Education

Bachelor/Masters in Engineering or Science

Tools

Quality risk management

Job description

Validation & Engineering Group, Inc. seeks a Quality Assurance Engineering Lead to oversee global engineering programs, ensuring GMP compliance, contamination control, and product quality across biologics, API, aseptic manufacturing and medical devices.

You will act as the primary QA representative on cross-functional teams and drive risk-based decisions. Responsibilities include governance of QA activities from design reviews to qualification, leading contamination control strategies, and