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: Quality Assurance Manager
Job Description:
*Ensure that QA audits of clinical trial data are conducted in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements.
*Coordinate the QA function for other ICON offices as agreed.
Additional Responsibilities:
*Manage the allocation of workload and supervision of auditors in the relevant office.
*Train QA auditors and assist in training other staff regarding GCP, ISO 9000, role of QA and regulatory audits etc, as required
*Plan and conduct QA audits and reviews as required in order to assure that clinical studies managed by ICON are of the highest standard and in compliance with the requirements of ICON or Sponsor SOPs, study protocols, ISO 9000 and Good Clinical Practice.
*Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively.
*Ensure that relevant new contracts / cost proposals are reviewed in order to enable the preparation of audit plans.
*Proactively develop and maintain the ICON quality systems and procedures, in line with changes in laws, standards and regulations and to ensure process improvements.
*Perform the QA Review on SOPs when designated this responsibility.
*Liaise with clients and project managers on quality aspects of studies including the attendance at marketing meetings, project meetings, oral presentations and audits.
*Ensure that all personnel are aware of the ICON requirements for quality.
*Conduct induction/orientation of new staff in ICON quality policies and procedures.
*Assist with the preparation of the local department budget and ensure effective cost control.
*Keep the person to whom the QA Manager reports informed of any QA issues within the department/office that require attention.
Candidate Profile:
Background in medicine, science and/or other relevant discipline and appropriate experience, such as Good Clinical Practice.
Extensive experience in Quality Assurance auditing some of which should have included management/supervisor responsibilities.
People management skills, including the ability to supervise, train and develop staff and to delegate effectively.
Change management skills and the ability to secure staff commitment to change.
In depth knowledge and understanding of drug development and the clinical trial process.
Highly developed problem solving skills, and the ability resolve difficult situations.
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
Team building and leadership skills.
Demonstrated training skills, including the ability to give constructive feedback.
Ability to gain the confidence and cooperation of colleagues.
Cost consciousness, with good commercial awareness and customer focus.
Ability to multitask and to work efficiently and independently under pressure.
Ability and willingness to travel at least 35% of the time (international and domestic).
Manage the QA department in the relevant ICON office, including assignment of workload, scheduling of audits, supervision of auditors and review of audit results.
Implement and maintain an effective QA function within the local office.
Fluency in English and either Chinese or Malay
Additional Information:
Experience: 1-2 years exp
Location: Bangalore, Beijing, Singapore, Taiwan
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job Code: 9927
End Date: 24th July, 2012
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