Career Opportunities

Directory, Quality & Regulatory

Posted on: Monday, August 5, 2019
Organization: iuvo BioScience
Location: Rush, NY
Description:

SUMMARY

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

  • Development of quality program to meet company, FDA/QSR regulations, ISO 13485 and ISO 17025 standards and customer requirements
  • Ensure FDA compliance to applicable CFR requirements (to the extent applicable): Part 58, 210/211, 820, 312/812, 314/814, etc. (GLP regulations, pharmaceutical GMPs, medical device GMPs, GCP regulations, etc.) and applicable GxP guidance documents
  • Ensure Compliance with appropriate / applicable international standards (i.e. ISO, ICH)
  • Evaluate processes, changes and improvements for Quality impact, participate in a leadership-based team to determine implementation and effectiveness of quality based changes
  • Create and maintain key performance indicators (KPIs) and report to ELT

Managerial duties

  • Manage all aspects of the Quality System, including but not limited to: CAPA, Complaints, Document Control, Change Control, Final product/service review and release (as applicable), Internal and external audits, risk management
  • Manage regulatory registrations and filings
  • Oversee all activities and personnel in the QA/Regulatory department (i.e. Manage work assignments; hire, supervise, develop and evaluate personnel; provide career development coaching and opportunities)

Leadership Responsibilities

  • Create and maintain a high commitment to quality and compliance
  • Maintain positive relationships inside and outside the company
  • Lead and motivate employees in all his/her areas of responsibility within the company
  • Strengthen/Maintain a commitment to internal and external customer service
  • As a member of the Executive Leadership Team, responsible for: contributing to the development and evaluation of the Strategic Plan, yearly operating plan, supporting revenue plans and operational growth strategy, other tasks as assigned by CEO (including development of revenue-generating quality and regulatory offerings)
  • Key member of the iuvo BioScience Operations Leadership Team (iBOLT)
Requirements:

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.

Education

  • Bachelor’s degree in science, engineering or relevant field; MBA preferred but not required. Minimum 8 years’ experience in quality and/or regulatory affairs. 

Expertise and Experience Required

  • Experience in the medical device and/or pharmaceutical industry a must.  Experience with GLP, GMP and GCP requirements, as well as interactions with Regulatory bodies, required.  Demonstrated proficiency as part of an executive leadership team required.

COMPUTER SKILLS

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.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

Ability to perform the calculations used in manipulating routine laboratory data.

REASONING ABILITY

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

N/A

PHYSICAL DEMANDS

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.

WORK ENVIRONMENT

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.

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