Quality Assurance Auditor, Quality & Compliance

QA Auditor, Quality & Compliance

Locations possible : Mexico City (Mexico),   Sofia (Bulgaria), Warsaw (Poland), Bratislava (Slovakia), Chennai (India)  

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Here at ICON we are looking for a candidate with Data Management experience to join our Quality & Compliance team as a QA Auditor. This role is focused on conducting agile and risk-focused snapshot audits and assessments of projects, processes and departments. The ideal candidate will be able to provide value-added information in a timely manner, enabling the business to understand and mitigate quality and regulatory risks.

Key responsibilities:

• Conduct audits, assessments and in-depth analysis of business processes and functional areas in terms of quality, regulatory and compliance related risk, and communicate the output to different levels of the organisation

• Lead and participate in multiple assignments; provide effective updates to stakeholders

• Successfully balance a combination of short and long term goals for assigned area of responsibility

• Guide and support team members in prioritising, troubleshooting, and contingency planning

• Participate in training & mentoring of new or developing team members

• Assume additional responsibilities, which are directed by the Q&C Manager or higher

To be successful in this role, you will have:

• A background in Data Management in a GCP environment, with experience with internal or external audits a plus

• An analytical mind-set, with the ability to understand complex issues and their implications. This includes condensing complex data into concise, relevant information, focusing on what matters for patient safety, data integrity, regulatory compliance, and other business needs.

• Effective communication skills and ability to interact with different levels of the organisation

• Proven ability to adapt to new ways of working with a focus on efficient, agile, and data-driven approaches

• Understanding of the CRO industry and specific operational processes

• Proficiency in standard office packages such as MS Office

• Capability to work as part of a team, as well as independently, to achieve department objectives and goals

• Effective time management skills and ability to prioritise, lead, and participate in multiple projects simultaneously

• Bachelor’s degree or higher in life sciences, or similar area, or relevant experience in clinical trials

• One to three years’ experience in a CRO, Pharma organisation, or equivalent environment

• Working knowledge of GCP guidelines and expectations pertaining to clinical trials

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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