Ref #: 27902

Employment type: Permanent - Full-Time

Location: US-NY-New York City

Posted: 12-Mar-2021

Description

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON DOCS, we have an incredible opportunity for an expert Quality Compliance Managers to join the team in the US. Multiple positions available for home-based Quality Compliance Managers throughout the US.

The Quality Compliance Manager 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

What you need:
• BA/BS degree required
• 4-8 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.
• Requires knowledge of the drug development process, good knowledge of worldwide GCP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques
• Risk Management experience is required
• Strong working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
• Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.