QA Manager
Frontage Laboratories
Summary
We are seeking a senior GLP quality assurance leader to oversee site quality assurance personnel, manage compliance program, host regulatory and sponsor inspections, and ensure adherence to FDA GLP standards for preclinical safety and toxicology testing.
Job description
Roles and Responsibilities
- Leadership to build, manage and enable the QA team to have 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, and 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, documents 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 constraint
- Demonstrate the ability to contribute to the success of assignments
- Perform other duties as assigned by Management
Education and 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)
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 Insurance
- Dental Insurance
- 401(k) Plan
- Short-term Disability Insurance
- Long-term Disability Insurance
- Life Insurance
Company overview
Frontage Laboratories is a leading global Contract Research Organization (CRO) established in 2001 and headquartered in Exton, Pennsylvania. As an FDA-registered and inspected pharmaceutical development organization, Frontage provides comprehensive, science-driven services throughout the entire drug discovery and development lifecycle. The company operates 26 state-of-the-art facilities across North America, Europe, and Asia, serving biotechnology and pharmaceutical clients of all sizes. Frontage's integrated service portfolio includes drug discovery, drug metabolism and pharmacokinetics (DMPK), preclinical safety and toxicology, formulation development and manufacturing, analytical and bioanalytical testing, clinical trials, and central laboratory services. With over 1,800 employees worldwide, the company has established itself as a strategic partner in advancing innovative therapies from early discovery through regulatory submissions and commercialization. Frontage's expertise spans small molecules, biologics, cell and gene therapies, and agrochemicals, supported by GLP/GCP-compliant operations and a robust quality assurance framework that enables clients to navigate complex regulatory pathways in the US, EU, China, and other global markets.