GLP Quality Assurance, Group Leader

Wuxi AppTec - Plainsboro, NJ (30+ days ago)2.8


Overview
Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. WuXi AppTec,Xenobiotic Laboratories (XBL) is seeking a GLP Quality Assurance, Group Leader located in Plainsboro, NJ.

Responsibilities

Primary Duties and Responsibilities:
Maintain a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP), and related regulations, as they may apply to WuXi AppTec (NeJ) activities.
Monitor study conduct, study set-up, sample collection, analysis and reporting for applicable regulatory compliance, including assurance that laboratories are run according to regulatory requirements and are meeting data integrity requirements.
Assist QA leadership in the development and implementation of updates to the company GLP program for adherence to FDA, EPA, OECD, and any other related applicable regulations within the facility.
Lead the QAU on inspection of facilities and evaluates current laboratory practices. Recommends changes or modifications to facilities and laboratory procedures that will maintain the facility compliance with current agency standards and regulations.
Monitor GLP off-site/subcontracted studies or study phases, as appropriate.
Lead and/or vendor and/or subcontractor qualification inspections.
Conducts audit (protocol/plan, raw data, and report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and in-process critical phase inspections of each GLP-regulated study performed at the laboratory for conformance to final protocol, SOPs, and relevant GLP regulations.
Oversee the maintenance of written records of all inspections/audits, as well as, submissions to the study director and management of inspection/audit reports, indicating deviations from or conformance to GLP, protocols, or SOPs.
Assist QA leadership in the review, writing, and maintenance of SOPs for the QAU and assists in the updates of general standard operating procedures, when necessary.
Develop and present GLP training programs for QA and technical laboratory personnel.
Oversee update and maintenance of the master schedule.
Assist QA leadership with arranging, scheduling, and assisting sponsors’ Quality Assurance inspections and regulatory agency inspections. Lead inspections by external parties in the absence of QA leadership.
Communicate with and serves as liaison to sponsor and outside agency QA inspectors as may be called for by QA and WuXi AppTec (NeJ) management.
Serve in advisory capacity to other personnel within the company in providing assistance in Good Laboratory Practices.
Serve as mentor and peer-reviewer to personnel in QA department.
In the absence of the QA leadership, the Group Leader will oversee the QAU and fulfill the required management responsibilities.
Other duties, as assigned by QA leadership.

Qualifications

Experience / Training / Education:
Bachelor’s degree, or higher, in a scientific discipline
At least 10 years of Quality Assurance experience; preferably in GLP-regulated bioanalysis
Experience working in a GLP-regulated research laboratory environment
Any similar combination of education and experience

Knowledge / Skills / Abilities:
Knowledge of commonly used concepts, practices, and procedures within the bioanalytical and QA field
Thorough understanding of Good Laboratory Practices and/or other regulatory guidelines applicable to EPA/FDA/OECD regulations
Must work well with numbers
Detail-oriented and highly organized
Computer skills: working knowledge of MS Word, Excel, Outlook, and PowerPoint
Ability to multitask and work under pressure of multiple projects and deadlines
Ability to effectively prioritize workload and manage changes in direction
Ability to work effectively in a multitasking environment; ability to communicate effectively with a highly diversified group of scientists, managers, and QA personnel
Must be able to record and keep essential records for a regulated environment
Must be able to adherence to regulatory guidelines consistent with WuXi AppTec requirements
Equal Opportunity Employer Minorities/Women/Veterans/Disabled