Onsite Vice President, Quality

Posted 4 hours ago

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About the role

  • Vice President of Quality leading QMS execution and quality strategies for BioTissue. Responsible for regulatory compliance and quality assurance initiatives within the organization.

Responsibilities

  • Proactively develop, lead and drive the execution of Quality strategy and oversight for BioTissue.
  • Lead the development, management and continual improvement of the Quality Management System (QMS).
  • Establish and maintain the quality system, developing quality policies and objectives.
  • Lead external and internal audits, complying with various regulatory requirements.
  • Serve as a key leader at BioTissue, ensuring QA/QC objectives are met.
  • Mentor the Quality organization, ensuring appropriate levels of accountability.
  • Responsible for the Quality Control function as it pertains to Environmental Monitoring and Quality Assurance activities.
  • Responsible for strategic leadership of the company’s Quality Management System (QMS).
  • Facilitate management review of QMS to monitor performance.
  • Support personnel with MDR/HHE reporting as well as the Change Control and CAPA processes.
  • Set and maintain regulatory policies and quality standards for all quality systems.
  • Drive execution of QMS processes through programs, policies and functions that support corporate and product quality.
  • Collaborate cross-functionally with internal departments on strategy development and implementation of quality principles.

Requirements

  • Bachelor’s degree in a related field, required
  • Master’s degree in a related field, preferred
  • Certified Quality Auditor (CQA), preferred.
  • 15 years’ minimum experience in quality within the biotech, medical device and pharmaceutical industry, preferred.
  • Proven track record of leading Quality programs and related activities in large organizations.
  • Strategic thinker and strong interpersonal skills suited for communicating and effectively working with C-suite executives.
  • Good advisory skills.
  • Highly motivated, excellent written and verbal communication skills, strong analytical and leadership skills.
  • Work under pressure and excellent organizational management skills.
  • Position requires high integrity and ethics.
  • Ability to develop and present regulatory and quality data and strategies.
  • Skilled in budget preparation and fiscal management.
  • Advanced knowledge and understanding of medical principles, methods, and procedures.
  • Excellent mentorship, and people management skills and the ability to manage projects and achieve results through others.
  • Working knowledge of conflict resolution and mediation principles and techniques.

Benefits

  • Sedentary work that generally requires sitting and/or standing

Job title

Vice President, Quality

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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