• NESCO Resource
  • $165,260.00 -165,260.00/year*
  • Rush , NY
  • Pharmaceutical/Biotechnology
  • Full-Time
  • 591 Fishell Rd

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. 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

  • Bachelors required, MBA Preferred


Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.



Associated topics: editor, fda, law, medical writer, regulatory, regulatory affairs, scientific journal, write, writer, writing

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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