Directory, Quality & Regulatory
|Posted on:||Monday, August 5, 2019|
Executive leader responsible for overall quality and regulatory leadership and compliance. Establishes a continuous improvement culture to ensure systems and processes are developed, maintained, and designed to scale for a growing business. Oversees all Quality Assurance/Quality Control and Regulatory programs and personnel for iuvo BioScience and Oculos. Responsible for all compliance activities relating to regulatory agencies and standards governing activities. Responsible for developing the plans, process controls to ensure compliance to regulations, standards, and customer requirements. Primary liaison with customers, regulators, notified bodies, etc. as it relates to matters of quality and regulatory affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Quality / Regulatory Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Expertise and Experience Required
Strong computer skills, including experience with word processing, Excel and other spreadsheet programs, Microsoft Outlook or equivalent; experience with electronic quality management system a plus.
Expert ability to read and interpret documents and reports. Must have excellent proofreading, spelling, grammar, and writing skills. Must have the ability to speak effectively before senior management, Regulators, groups of customers and employees of the organization. Must have well-developed interpersonal communication skills.
Ability to perform the calculations used in manipulating routine laboratory data.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Must be able to schedule tasks, organize time, and plan ahead.
OTHER SKILLS and ABILITIES
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit, stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Combination of office and laboratory settings with occasion for exposure to fumes or airborne particles, toxic or caustic chemicals and biological hazards. Moderate noise levels exist.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
For more information, or to apply, please contact us at HR@iuvobioscience.com.