ICON Strategic Solutions · 1 day ago
Manager GCP Process Development
United States
Full-time
Remote
Mid, Senior LevelICON plc is a world-leading healthcare intelligence and clinical research organization. As a Manager, Clinical Quality Compliance, you will ensure that clinical trials adhere to the highest standards of quality and regulatory compliance, contributing to the advancement of innovative therapies through strategic oversight of quality management systems.
Pharmaceuticals
Responsibilities
Leading the development and implementation of quality assurance strategies to ensure compliance with regulatory requirements and industry standards in clinical trials
Collaborating with cross-functional teams to conduct audits, inspections, and quality assessments, providing actionable insights for continuous improvement
Monitoring and analyzing quality metrics to identify trends and areas for enhancement in clinical operations
Providing training and guidance to staff on compliance standards, fostering a culture of quality and accountability within the organization
Building strong relationships with regulatory agencies and internal stakeholders to facilitate smooth communication and compliance initiatives
Qualification
Required
Advanced degree in a relevant field such as life sciences, clinical research, or a related discipline
Extensive experience in clinical quality assurance or compliance, with a thorough understanding of regulatory requirements and quality management systems
Strong leadership skills with the ability to inspire and manage teams effectively in a fast-paced environment
Proficiency in quality assessment tools and methodologies, with a focus on risk management and mitigation strategies
Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive a culture of compliance
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s 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’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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
Company data provided by crunchbase