Quality Assurance, Manager EGeen International
THIS JOB HAS EXPIRED Description
The Manager, Quality Assurance, reporting to the Medical Director, will play a key role in ensuring GCP compliance at investigator sites and selected vendors, as well as reviewing clinical study reports, documents and regulatory submissions for clarity and accuracy. All sites and most vendors located in Eastern Europe, and frequent travel (up to 50) is required.
EGeen is a transatlantic CRO whose key business focus is to advance the drug development of biotech and pharmaceutical clients via expeditious and high quality yet cost-effective clinical trials. Headquartered in California since its inception in 2001, EGeen has wholly owned subsidiaries in Estonia, Ukraine and Romania with operations in several Eastern European and Scandinavian countries. It was funded by premier US and international venture capital and private equity funds, and currently employs 50 people in the US and Europe in marketing, clinical trial management and monitoring, QA, logistics and IT support.
Establish clinical QA system that is appropriate for studies and aligns with existing global Quality Assurance program.
Conduct analysis at existing sites and develop any missing clinical quality assurance systems towards ICH/GCP compliance of study and data integrity.
Develop, maintain and execute clinical QA audit plans, Internal Audit Policy for clinical operations and related processes, and international field sites where studies are conducted
Plan, schedule, conduct/oversee internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analyses of clinical international field sites.
Identification and preparation of SOPs which are missing in the system
Periodic review, distribution, maintenance, withdrawal and archiving of SOPs
Induction and training of new employees and ongoing training of SOPs and GCP
Facilitate the training of company personnel to Quality System, SOPs and WPGs
Control that ensure SOPs are followed, skills and procedures are executed according to established standards, and document outcomes.
Participate in/initiates clinical development departmental activities as assigned and as needed, e.g., drafting/reviewing operational procedures, promoting and participating in team building activities, departmental meetings, identifying and coordinating with external experts for presentations, etc.
Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, following up on action items
Remains current in knowledge of clinical trail methodology, GCP, ICH, FDA, EMEA, and other local/international regulatory guidelines and requirements, through attendance at training courses, literature review, etc.
Function as liaison in a regulatory inspections/client audits
Communicate with executive management, via presentations and/or technical reports, regarding Quality Systems, audit/inspection findings and trend analysis
Education and Experience:
Bachelors degree in science or health-related field or equivalent experience in clinical research GCP auditing.
Minimum of 5 years experience of clinical trials.
Minimum of 2 years Q/A and auditing experience, management experience in quality assurance or clinical trial operations.
Understanding of and compliance experience with CFR 21 GCP regulations and guidance, EU Clinical Trials Directive
Knowledge and Skills:
Auditing process of clinical trial facilities; CRO's, IRB's, and other GCP vendors
Extensive knowledge of Good Clinical Practices and applicable code of Federal Regulations
Computer skills to include Excel, Power point, MS Project, and Visio
Excellent interpersonal and communication skills
Good Laboratory Practices Standards
Intimate knowledge of pharmaceutical industry GCP requirements, and related US and international laws; Ex-US experience is a plus.
Adept problem finding / solving and organizational skills.
Experience in training and implementing procedures compliant with FDA/ICH/WHO guidance or regulations.
Excellent command of the English language, demonstrated by strong verbal and written communication skills; the ability to present effectively.
Ability to work in a dynamic organization with aggressive timelines and multiple priorities.
Ability to coordinate, manage, and motivate internal and external compliance personnel.
Ability to travel minimum 50.
Well organized and detail-oriented.
Willingness and capability to "roll up one's sleeves" in order to achieve goals.
||1949 Landings Drive |
Mountain View, CA 94043
THIS JOB HAS EXPIRED