Quality Manager

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.

As a Quality Manager you will be responsible for the Quality Management System and providing support in the areas of quality issue management as well as corrective and preventive actions (CAPA) management.

You will be joining a large international pharmaceutical company. The company’s main focus is providing life-changing innovations to help improve people’s quality of life and a great place to work.  They make a positive difference in people’s lives and use science to drive progress.

What you will be doing:

• Proactively assist with the implementation and maintenance of an effective Quality & Compliance (Q&C) programme
• Maintain and approve assigned quality issues and CAPAs in the electronic Quality Management System (eQMS)
• Support the internal customer for the assigned records in the quality issue and root cause/CAPA process
• Contribute to the process monitoring and continues improvement of the Quality Issue and CAPA process, including maintaining metrics and KPIs and performing overseeing the data quality in the eQMS
• Drive quality into the business through proactive quality support, training, mentoring and/or coaching, and consultation (quality by design)
• Advises internal customers, as well as functional lines, and stakeholders on how to address issues while maintaining compliance with worldwide regulations, guidelines
• Contribute and participate in health authority inspections

You are:

• At least 3 years of relevant experience in Quality Assurance (QA) experience or in international pharmaceutical and/or biotech industry, quality management, clinical development, or regular compliance with extensive knowledge in clinical development QA
• Broad knowledge/expertise in continuous improvement with background in appropriate tools/procedure e.g. strong quality orientation and understanding of metrics; Lean Six Sigma training or alternative trainings
• Excellent knowledge of applicable worldwide GCP regulations and ICH guidelines, and applicable worldwide computerized system validation principles (e.g., GAMP5)
• Basic knowledge of other GxP disciplines like GVP, GLPs, GRPs or GMPs
• Broad understanding of the drug development process and regulatory environment
• Excellent communication, problem-solving, and organization skills
• Fluent in written and spoken English
• Happy to travel occasionally 

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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.

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