Clinical Quality Compliance Specialist

As a Quality Monitoring & Compliance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

Develops and maintains quality monitoring plans for assigned programs. Executes and/or oversees the implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. Ensures agreed upon deliverables are completed within the timeframe established, including but not limited to review and assessment of Quality Risk Management reports; coordination of quality risk mitigation plans for identified issues; quality reviews of key clinical trial documents, and review and planning of submission activities as needed.

Supports Due Diligence activities, as requested, liaising with the applicable business and R&D Q&C L&A coordination personnel. Provides Good Clinical Practices (GCP) guidance to workgroups and to business partners. Ensure interpretation and consistency with compliance guidance provided. Assists in the facilitation of inspections by regulatory authorities for GCP, supporting R&D Q&C as appropriate.

Deliverables:

• Develops Quality Monitoring Plans and performs/oversees performance of quality

monitoring activities for assigned projects or other projects/tasks, as assigned, according to agreed upon deliverables and established timelines.

• Provide ongoing compliance support to business partners, including but not limited to:
• Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk.  Collaborates with applicable team members to develop risk mitigation plans.
• Providing compliance support in the management and implementation of quality risk mitigation and inspection readiness actions identified following QM&C assessments for assigned programs.
• Collaborating with the Clinical Team business partners to share audit/inspection observations

for lessons learned across protocol, and/or program, and working with the appropriate business partners and appropriate groups within RD Q&C to implement Corrective Action Plans

• Provide compliance direction/support to applicable clinical team members on an ongoing basis.
• Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities
• Supports the facilitation of inspections by health authorities for GCP, in liaison with RD Q&C

as appropriate

• Supports special projects, as assigned by supervisor. May mentor new employees

• Advanced:

o provides appropriate QM&C support to assigned cross-functional workgroups.

o Responds independently to GCP-related compliance inquiries from other departments.  Confers with quality professional staff when contacted for pro-active consultation to provide regulatory insight.

o Manages inspection preparation activities and supports business during health authority inspections, in liaison with R&D Q&C as appropriate.

You are:

• A Bachelor of Science (BSc) or Arts (BA) degree or equivalent degree is required. A minimum of 3 years experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is

required.

o Advanced: 8 years experiences

• Requires knowledge of the drug development process, good knowledge of

worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques

• Ability to interpret data to develop action plans to improve business.
• Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills;
• Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• Ability to translate data into information and strategies into executable action plans.
• Minimum of 3 years of progressive business experience, with exposure to the pharmaceutical R&D environment.

o Advanced: minimum of 8 years of business experience.

• Ability to motivate professional colleagues and stakeholders
• Conflict resolution/management and negotiation skills
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Experience of the key customers’ business processes and practices; experience of the overall

drug development process is an asset

• Knowledge of the overall drug development process;
• Strong working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
• Experience with regulatory submissions (NDA, BLA);
• Good knowledge of English is required;
• Proficient in Microsoft Office applications
• Problem solver

• Proactive strategic thinker
• Strong leader and collaborator
• Highly committed to quality
• Flexible and persistent
• Good conflict handling/negotiation skills
• Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
• Excellent communicator and presenter, with excellent interpersonal skills and diplomacy
• Excellent knowledge of English is required
• Proficient in Microsoft Office applications
• Able to create win-win situations with internal and external partners
• Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy
• Knowledge of the corporate structure and culture
• Requires little supervision and functions independently.  Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

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.