Regulatory Compliance Director
Regulatory Compliance Director
IQVIA Laboratories
About
IQVIA Laboratories is a global leader in drug discovery and development laboratory services, offering a comprehensive suite of central laboratory and specialty biomarker services. Our expertise spans genomics, immunoassays, flow cytometry, anatomic pathology, precision medicine assays, vaccine assays, ADME, and bioanalytical services.IQVIA Laboratories also specializes in antibody and biomarker discovery, as well as decentralized clinical trial laboratory solutions. Committed to scientific rigor and operational excellence, we support every phase of the drug development and discovery process across diverse regions and regulatory frameworks, ensuring the highest standards of data integrity and accelerating the delivery of transformative therapies to patients.
The position will be located at the IQVIA Laboratories facility in Livingston, Scotland. Hybrid and flexible working patterns will be considered.
Join us on our exciting journey!
Job Overview:
This role will be responsible for ensuring ongoing regulatory compliance within the IQVIA Laboratories’ Central Laboratories functions. The role will work directly with customers, third party providers and internal stakeholders to assess compliance and provide guidance on appropriate solutions based on intended use of each item/method.
The role will also oversee the creation and ongoing management of a central repository/knowledge base of regulatory compliance status and will ensure collation of study specific regulatory compliance documentation is created as required. The position will also support customer audits/inspections to provide documentation on the procedures surrounding regulatory compliance of analytical methods and consumable products used.
This will be a leadership-level position reporting to senior management of the IQVIA Laboratories’ Central Laboratories and will work alongside the Regulatory Affairs department to ensure full operational compliance.
Requirements:
- Candidates must have at least 10 years of experience in the clinical trial or medical device domain, ideally both, with a deep understanding of current global regulatory requirements, including IVDR and FDA LTD regulations.
- Must possess strong interpersonal skills for interacting with senior members within sponsor organizations and demonstrate the ability to meet deadlines.
- Proven experience in successfully working on and delivering clinical trials.
- Experience in customer management and strong relationship management skills.
- Good organizational and project management skills.
- Demonstrated proficiency with Microsoft Office and LIMS systems.
- Must understand medical and clinical research terminology.
- Knowledge of global regulatory requirements for conducting clinical trials in central laboratories, including IVDR.
- Experience working within ISO 13485.
- Understanding of the process for submitting technical and conformity declaration documentation.
- Prior knowledge of IQVIA Labs processes and computer systems is highly desired.
- Work-Life Balance, with a strong focus on a positive well-being.
- Continuous career development and growth opportunities.
- Variety of therapeutic areas
- Collaborative and supportive team environment
- Access to cutting-edge and innovative, in-house technology
Learn more at https://jobs.iqvia.com