QA Manager

Frontage Laboratories•Concord Township, OH

30d•Onsite

About The Position

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.

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).

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.