QA Manager

About This Role

Managing the quality assurance team, ensuring compliance with FDA GLP standards, and leading regulatory inspections are the core functions of this senior GLP quality assurance leadership role. The position involves overseeing preclinical safety and toxicology testing within the company's laboratories.

Responsibilities

• Provide leadership to build, manage, and enable the QA team to achieve peak performance
• Drive continuous process improvement and develop a risk-based QA management strategy to achieve quality and productivity goals
• Manage, schedule, perform, and supervise audits and inspections of critical study phases, equipment, facilities, protocols, experimental data, and reports
• Host and organize site inspections and audits by government agencies and sponsors
• Assess the GLP compliance level and quality test sites and contractors
• Interface with Frontage Laboratories' Global Quality Assurance
• Author or review Standard Operating Procedures
• Summarize inspection/audit findings, document Quality Assurance activities, and recommend improvements to the QA program
• Administer and conduct GLP training and manage quality compliance across facilities
• Complete tasks within time and budget constraints
• Demonstrate the ability to contribute to the success of assignments
• Perform other duties as assigned by Management

Requirements

• Bachelor’s Degree in Life Sciences or related discipline
• Minimum of five years of experience in preclinical safety & toxicology GLP, including hands-on interaction with government regulatory agencies
• Excellence in strong leadership, communication, multitasking, problem-solving under pressure, and proficiency in standard office software (Microsoft Office, Adobe PDF)

Benefits

• Health and dental insurance
• 401(k) plan
• Short and long-term disability insurance
• Life insurance

About the Company

Frontage Laboratories Inc. is an award-winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, experiencing significant year-over-year growth. Its core competencies include pre-clinical, drug metabolism, pharmacokinetics/pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.