Title: Manager/Senior Manager/Associate Director/Director, Quality Assurance
Location: Concord, OH
Reports To: Senior Director/VP of Quality Assurance
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, growing significant YoY growth. Our 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.
Position 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.
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).
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Bachelor's degree in Life Sciences or a related discipline
- At least five years of experience in preclinical safety and toxicology GLP
- Hands-on interaction with government regulatory agencies
- Strong leadership, communication, multitasking, and problem-solving skills
- Proficiency with Microsoft Office and Adobe PDF software
Frontage Laboratories, Inc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Frontage Laboratories, Inc and has not been reviewed or approved by Frontage Laboratories, Inc.
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Healthcare Strength — Health insurance is often described as good or affordable, with medical, dental, and vision consistently included. Feedback suggests this coverage stands out as a solid element of the package.
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Retirement Support — A company‑matched 401(k) is frequently mentioned and at times characterized as competitive. Access to retirement savings with an employer match is viewed as a meaningful benefit.
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Leave & Time Off Breadth — PTO is offered with floating holidays and some carryover, with reports of about three weeks to start in certain roles. These features indicate a reasonably comprehensive time‑off structure.
Frontage Laboratories, Inc Insights
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
