Clinical Quality Compliance Lead

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

Partner with Senior Manager, Opex & Compliance (SMOC) to ensure ongoing compliance to appropriate Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations and guidelines.

Principal Responsibilities:

Quality Issue Management Support:

Support Medical Affairs Unit quality issues that need to be captured in QMS:

• Liaise with investigation owner and CAPA Manager to identify appropriate CAPA owner (study specific vs. general/systemic issue)
• Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the CAPA Manager
• Assist the Investigation Owner and CAPA Manager in the application of structured problem‐solving methodologies in Root Cause Analysis (RCA) investigations in support of the Root Cause Investigation team

Support Medical Affairs Unit issue owner on logistical aspects of issue resolution:       

• Identifying additional stakeholders if needed to support RCA investigation and resulting actions
• support discussions with stakeholders
• Keep oversight on CAPA milestones together with CAPA Manager
• Timely escalate systemic issues identified during issue discussion to SMOC
• Track quality issues with respect to timelines and affected areas/topics

Audit & Inspection Support:

• Monitor audit and inspection announcements to ensure timely involvement of Medical Affairs Unit SMEs in support of audit and inspection readiness
• Support SMOC with document or data requests during internal audits and inspections by engaging appropriate Medical Affairs UnitSMEs
• Support SMOC and/or responsible issue owner after audit and inspection on CAPA activities

Process Governance Support:

• Support SMOC to identify appropriate SME to represent Medical Affairs Unit for procedural document review/creation
• Track ongoing procedural document review/creation activities for timely involvement and completion (timelines come from aSIST tool and cross-pharma review)
• Work with Medical Affairs Unit and cross-functional BPOs on relevant procedural document updates related to CAPA commitments

You are:

• A minimum of 5 years of previous Pharmaceutical Industry experience is required, with at least 3-4 years of GXP experience within clinical research and development and/or quality assurance.
• Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause Analysis.
• Knowledge of the overall drug development process
• Well-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Planning and tracking skills, able to see the big picture, well organized, focused on results, customer focused, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
• 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

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.