Quality Lead

Summary: Seeking a Quality Lead to support the QISM group with a focus on IT Infrastructure and Clinical Operations, ensuring compliance and data integrity in computerized systems.

• Job Requirements:

  • Bachelor's degree and relevant GxP work experience
  • Proficiency in Microsoft Office applications
  • 8-10 years of experience performing validation activities

• Preferred Skills:

  • Experience with Clinical Computerized Systems / Infrastructure Quality Assurance
  • Familiarity with FDA / MHRA regulations
  • Use of computerized quality management systems
  • Validation of Enterprise / Lab Computerized Systems
  • Knowledge of quality metrics, dashboards, and improvement programs
  • Understanding of GAMP and Agile validation methodologies

• Job Responsibilities:

  • Provide oversight for computerized system implementation, maintenance, and retirement
  • Review and approve system lifecycle documentation for GxP areas
  • Identify high-risk areas focusing on patient safety, product quality, and data integrity
  • Escalate risk or non-compliance issues to leadership
  • Participate in Periodic Review activities of Computerized Systems
  • Support regulatory inspection preparedness activities as needed

Pay Details: $42.00 to $57.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance