Senior Quality Process Specialist

Senior Quality Process Specialist - Poland, Warsaw

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Quality Process Specialist to join our diverse and dynamic team. As a Senior Quality Process Specialist, you will perform tasks relevant to the assigned Quality & Compliance function including but not limited to two main activities, Conducting Snapshots - Internal Quality Assessments and Fulfilling role of Q&C Business Partner during the SOP Harmonization.

Provide support to all roles for EDMS activities, Documentation guidance, Training identification and Cross SOP Harmonization workstream communications
Perform review of relevant study data as Trial Master File and other relevant data source
Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines. Understand key business drivers; uses this understanding to accomplish own work.
Build knowledge of the company, processes and customers.
Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.
Assume additional responsibilities, which are directed by the Q&C Manager or higher.
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.

Background in medicine, science and/or other relevant discipline and appropriate experience.
Experience within Clinical Research Environment (e.g. CRA, Data Management) an advantage.
Ability to review and evaluate clinical data / records.
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
Detailed understanding of drug development and clinical trial process.
Good problem resolution skills.
Good planning and organizational skills with the ability to multi-task.

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

ICON, including subsidiaries, 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, colour, 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply