Overview:

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.
• Provides 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
• 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
• Provides compliance guidance and 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
• Supports special projects, as assigned, and may guide new employees

Experience and Education:

• Bachelors Degree or experience in lieu of degree
• 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
• Ability to interpret data to develop action plans to improve business.
• 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.
• 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 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
• Proficient in Microsoft Office applications

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $103,900.00 - $173,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.