Bioanalytical QA Manager

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The successful candidate will proactively assist with the implementation and maintenance of an effective Quality Assurance program within ICON. Responsible for oversight of CAPA program and review of audit results. Assignment of workload, scheduling of audits, and supervision of auditors. .  

Overview of the Role

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (up to 35%) domestic and/or international.
• 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, 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.
• Implements company policy, develop procedures where necessary 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, client relationship meetings, oral presentations and audits. Provide technical guidance to employees/colleagues and/or customers
•  Ensure essential procedures are followed*Train QA auditors and assist in training other staff regarding GXP, role of QA and regulatory audits etc., as required.
• To demonstrate leadership in the company and be able to work with departments to improve their overall performance and quality. Create an environment that motivates people, acting as a mentor and sharing expertise.
• *Assist with preparation, conduct and follow up of Sponsor and Regulatory audits and represent the QA internally and towards third parties.
• Impacts the results of the area of responsibility through the team’s ability to meet quality, volume and timelines objectives and/or inputs to decisions in their area of specialization
• *Contribute to ensuring effective budgetary control within the department.
• Perform departmental and ICON staff training regarding ICON's quality system, regulations and on external audits/inspections
• Ensure that relevant new contracts /cost proposals are reviewed in order to enable the preparation of audit plans. Guided by functional business plans and policies
• performance objectives and conducting of performance reviews
• Lead execution of team plans, sharing accountability for delivery of team’s end results.
• Champion and drive change in the team
• Adapt plans and priorities to meet operational challenges or provide advice to others in their area of expertise
• Keep up to date on competitor information and market trends
• Apply in depth understanding of how own team and/or specialization contributes to the achievement of departmental or functional objectives
• Identifies and resolves technical and/or operational issues, drawing on company policies and guidelines and identifying exceptions for further review
• Builds strong relationships internally and externally and influences others internally and in some cases externally
• Keep the person to whom the Manager, reports informed of any QA issues within the department/office that require attention.
• Assume additional responsibilities, which are directed by the Senior Manager QA or higher.

• performance objectives and conducting of performance reviews
• Lead execution of team plans, sharing accountability for delivery of team’s end results.
• Champion and drive change in the team
• Adapt plans and priorities to meet operational challenges or provide advice to others in their area of expertise
• Keep up to date on competitor information and market trends
• Apply in depth understanding of how own team and/or specialization contributes to the achievement of departmental or functional objectives
• Identifies and resolves technical and/or operational issues, drawing on company policies and guidelines and identifying exceptions for further review
• Builds strong relationships internally and externally and influences others internally and in some cases externally
• Keep the person to whom the Manager, reports informed of any QA issues within the department/office that require attention.
• Assume additional responsibilities, which are directed by the Senior Manager QA or higher.

Role Requirements / Skills / Experience Required

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• US/LATAM/CAN: A minimum of 5 years QA (or equivalent) experience in the pharmaceutical or CRO industry, with some previous management/supervisor responsibilities preferred
• In depth understanding of concepts, theories and principles in own discipline with some knowledge of other disciplines
• 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. 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.
• Knowledge of regulations, hosting audits, preparing audit reports, corrective and preventative actions (CAPA) and complaint handling.
• Excellent communication and interpersonal skills. Including the ability to liaise successfully with project teams, investigators and clients. Good command of the English language.

Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver’s license.

University/Bachelors Degree/Diploma in life science, or local equivalent qualification/relevant work experience. 

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.

What’s Next

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment.