ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Associate Director, Clinical Quality Assurance
Job Description:
· Ensuring that QA audits of clinical trial data are conducted effectively in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements
· Ensure consistency of auditor training and reporting on a regional basis
· Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance
· Manage the CQA group in the relevant ICON office(s), including assignment of workload, scheduling of audits, supervision of managers and auditors and review of audit results
· Train QA managers and auditors and assist in training other staff regarding GCP, ISO 9000, role of QA and regulatory audits, etc
· Ensure that all personnel are aware of the ICON requirements for quality
· Ensure that regular and random QA audits (internal and external) are conducted in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements
· Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively
· Liaise with clients and project managers on quality aspects of studies including the attendance at marketing meetings, project meetings, oral presentations and audits
· Proactively develop and maintain the ICON quality systems and procedures, in line with changes in laws, standards and regulations and to ensure process improvements
· Plan and co-ordinate specific projects related to the development and improvement of the ICON quality assurance clinical auditing program
· Prepare the local department budget and ensure effective cost control
· Ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary
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· Participate in professional development through journal articles and by presenting at and attending conferences and professional meetings
· Contribute to the growth of ICON by participating in stand-alone QA services, in collaboration with the business development group, and in line with market opportunities and available resources
· Ability and willingness to travel at least 35% of the time (international and domestic)
Candidate Profile:
· Must have a Bachelor’s Degree in medicine, science or equivalent degree/experience. A Master’s or Ph.D in life science, medicine, or related field would be a plus
· A minimum of 8 years experience in a quality / regulatory compliance position, with a record of success in providing quality and technical direction and organizational leadership in the pharmaceutical industry
· Strong knowledge and understanding of drug development and the clinical trial process
· In depth knowledge of current regulatory requirements. Experience with global regulations and guidelines would be an advantage
· Experience in developing and implementing Quality Management Systems
· Ability to impact organizational performance through strategic thinking leading to improved processes
· Must posses strong team building, management and communication skills with the ability to influence others and gain commitment
· Demonstrated training skills, including the ability to give constructive feedback
· Cost consciousness, with good commercial awareness and customer focus
· Ability to multitask and to work efficiently and independently under pressure
Additional Information:
Experience: Min. 8 Years
Location: Philadelphia/North Wales (PA)
Education: MS, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job ID: 2229
End Date: 25th Sept., 2011
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