Covance is hiring a Regulatory Associate Director in Indianapolis, Indiana to provide support on regulations and quality standards applicable to global Central Laboratory Services.
Relocation Assistance is available! Excellent opportunity to advance your career and join our global quality team!
The interpretation and application of CAP, CLIA, NYS and GCP regulations are essential functions of this role.
Clinical Trial Lab experience and previous quality assurance experience is also essential to the success of this function.
The Regulatory Associate Director is expected to remain current with the regulations, communicate the implication of those changes and assist the appropriate functional teams in updating appropriate procedures based on the new requirements.
Essential Job Duties Include:
• Plays a lead role in staying current with the regulatory landscape as it pertains to a central lab. Areas include but not limited to CDx, Dx, genomics and vaccines
• Interprets, assesses gaps with and assists the appropriate functional teams in modifying existing or creating new procedures and processes based on changes in regulations
• Identifies gaps in regulatory compliance and provides ways to mitigate risks as appropriate
• Designs and delivers training as necessary to enhance regulatory awareness throughout the organization.
• Work with the QA colleagues to ensure that global QA audit practices remain current with the regulatory requirements
• Enhances Covance’s external profile, and develops an effective network, through active participation in external industry and regulatory forums.
Covance, the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world’s most comprehensive drug development company. Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing -- We have helped pharmaceutical and biotech companies develop each of the top 50 prescription drugs in the marketplace today.
We also offer laboratory testing services to the chemical, agrochemical and food industries and are a market leader in toxicology services, central laboratory services, discovery services, and a top global provider of Phase III clinical trial management services.
Together with our clients, we create solutions that transform potential into reality.
This is an exciting opportunity to join our team!
• Bachelor of Science/Arts (BS/BA) degree in a science field
• Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)
• Masters Degree in a Science related field is preferred
• Process Excellence certificate preferred
• At least 10 years’ experience in a CAP/CLIA, GxP-regulated environment
• Clinical Trial Lab experience
• Quality Assurance experience
• Experience with Bioanalytical Assays is preferred