Job Description

Manager, Quality Assurance - Home based or Office based - Chennai or BangaloreICON plc is a world-leading healthcare intelligence and clinical research organization. We\xe2\x80\x99re 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 developmentWe are looking for an experienced Quality Assurance Manager to join our specialist team, to help support our business areas with corporate systems compliance, complex architecture and interoperability as well as data governance and data integrity.As a Quality Assurance Manager your role will involve:

• Providing cross-functional Quality Assurance expertise, supporting all areas of Data Integrity and Technology Compliance.
• Responsible for the oversight of the Computerized Systems Validation (CSV) review process and qualification deliverables to ensure documentation supports a compliant state.
• Supporting efforts for standardization and advancement of validation / qualification methodologies in support of software, equipment with software and medical devices used in a clinical setting.
• Responsible for analysing technology related risks and the creation, execution and oversight of Technology Audit schedules (Internal and Vendor).
• Supporting technology focused sponsor audits and inspections.
• Providing guidance to technology and information management groups to ensure the business understands applicability of associated published regulatory guidance or regulations concerning GCP, GLP, GMP, 21CFR Part 11, and Annex 11.
• Supporting training activities focused on advancing Systems Compliance SMEs across Quality and Compliance.
• Developing and fostering positive relationships with business unit customers to ensure a common understanding, approach and appreciation for computerized systems validation (CSV) and technical auditing, with focus on Data Integrity and system integration.

As a Quality Assurance Manager you will need:

• Degree level education

• Experience specific to the application or support of software validation and compliance efforts.
• Experience in QA, with GxP auditing, Data Integrity and CSV
• An understanding of validation and qualification strategies for regulated systems including software and medical devices used in clinical settings
• Demonstrated strength in agile working principles, methodologies, and team structures
• Expert knowledge with audit or inspection management
• Ability to travel as needed to vendor and/or internal sites

At ICON, it\xe2\x80\x99s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients\xe2\x80\x99 lives.Our \xe2\x80\x98Own It\xe2\x80\x99 culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That\xe2\x80\x99s our vision. We\xe2\x80\x99re driven by it. And we need talented people who share it.
If you\xe2\x80\x99re as driven as we are, join us. You\xe2\x80\x99ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you\xe2\x80\x99ll be helping shape an industry.Benefits of Working in ICON:
Our success depends on the quality of our people. That\xe2\x80\x99s why we\xe2\x80\x99ve 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 \xe2\x80\x93 both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans \xe2\x80\x93 and related benefits such as life assurance \xe2\x80\x93 so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you\xe2\x80\x99ll 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.What ICON can offer you:Our success depends on the quality of our people. That\xe2\x80\x99s why we\xe2\x80\x99ve 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 entitlementsA range of health insurance offerings to suit you and your family\xe2\x80\x99s needs.Competitive retirement planning offerings to maximize 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\xe2\x80\x99s well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our 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 .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless \xe2\x80\x93 there\xe2\x80\x99s every chance you\xe2\x80\x99re exactly what we\xe2\x80\x99re looking for here at ICON whether it is for this or other roles.Are you a current ICON Employee? Please click to apply

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