Clinical Quality Compliance Lead

6 days ago

Sydney, New South Wales, Australia Pharmiweb Full time
Clinical Quality Compliance Lead

As a Clinical Quality Compliance Lead at Pharmiweb, you will be part of the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

Key Responsibilities:

  • Support or lead inspection readiness initiatives under the Operations Quality Lead.
  • Create processes and tools to achieve inspection readiness within Development Operations.
  • Collaborate with QA, Operations Quality Lead, and Operations Quality Manager to facilitate growth opportunities.

General Responsibilities:

  • Develop and maintain guidance and processes to facilitate DOQ support of Study Teams.
  • Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis.
  • Provide training or awareness for new or established processes or guidance provided by DOQ.
  • Collaborate in developing and presenting DOQ content for distribution within the organization.
  • Author relevant content for the DOQ SharePoint site.
  • Act as lead on specified DOQ workstreams or assigned DOQ initiatives.
  • In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests that are sent to DOQ.
  • Consult, develop, or identify opportunities for continuous improvement projects.
  • Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations.
  • Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials.
  • Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus.
  • Develop matrix relationships to involve process experts and conduct improvement activities.
  • Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization.
  • Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do.

Requirements:

  • Bachelor's degree or equivalent with a strong emphasis on science or quality management.
  • Minimum of 5 years' experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
  • Minimum of 3 years' experience in quality role.
  • Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience.
  • Ability to travel.

What ICON Can Offer:

  • Competitive salary.
  • 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.

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

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