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Sr. Manager, Clinical Quality Assurance (CQA)

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About the role

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Senior Manager, Clinical Quality Assurance Role at ICON: 
 
Effectively implement, maintain and manage the activities of the Clinical Quality Assurance team in the Americas and ensure high performance and continuous development of staff.  Co-ordinate and manage audit workload assignments and ensure that audit programs are carried out In accordance with relevant procedures, timeframes and targets.  Provide expert clinical quality assurance input into new/current business opportunities, improvement projects and operational interactions
 
Who Are We?
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.
 
 
Benefits of Working at ICON:
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  We provide our Senior Manager, CQA with an excellent benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and an annual incentive plan to reward performance.  
 
 
Responsibilities:
  • Directly manage team of 9 Auditors located in the Americas
  • Effectively implement and maintain Clinical Quality Assurance procedures and processes in adherence with ICON SOPs, ICH GCP and appropriate regulations
  • Ensure all necessary training is provided to auditors to improve their performance and knowledge. Provide coaching/mentoring and a benchmark of auditing competencies, as necessary.
  • Effectively manage the CQA audit program including coordination of project allocation and ensuring that all necessary project assessments, audit schedules and plans are completed and cover areas of high risk.  Proactively flag potential issues to regional Director/Senior Director. CQA.
  • Provide expertise and leadership in Quality Compliance to the wider organization and ensure that all personnel are aware of ICON requirements for quality.
  • Perform the QA review for assigned procedures and act as an author/subject matter expert on procedures when designated this responsibility.
  • Effectively manage the tracking and analysis of defined CQA quality and performance metrics. Ensure CQA audits are conducted and reported according to relevant timeframes and plans and liaise with appropriate managers as necessary in order to achieve this.
  • Ensure regular analysts and reporting of audit trends for presentation to operational departments and for risk assessment and audit planning purposes.
  • Provide input into regional QA department budget in conjunction with the relevant Director/Senior Director and promote effective cost control.
  • Keep direct line manager informed of any quality issues within the department/office which require attention.
  • Manage the allocation of workload and supervision of auditors in relevant office(s).
  • Monitor metrics and QA reports and addresses performance issues and trends accordingly.
  • Perform required managerial tasks for staff such as performance review and setting clear goals and objectives.
  • Create an environment that motivates people, acting as a mentor and sharing expertise.
 
 
 
To Succeed You Will Need:
  • Bachelor’s Degree or local equivalent in medicine, science or equivalent degree/experience
  • MSc or PhD In life science medicine, or related field would be an asset
  • Minimum of 5 years active experience in a quality/regulatory compliance position, with a proven track record of success in managing quality projects and teams with broad quality assurance experience
  • Minimum of 3 years directly managing a team
  • In-depth knowledge and understanding of drug development and the clinical trial process
  • Thorough knowledge of current regulatory and ICH GCP requirements and experience with global regulations and guidelines, required
  • A satisfactory progression of auditing experience in pharmaceutical company or Clinical Research Organization (CRO)
  • Medical device auditing experience a plus
  • Highly developed problem solving skills and the ability to resolve difficult conflicts
  • Strong people 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
  • Willingness to travel approximately 35% domestic and international
 
 
What’s Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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