Vice President, Quality

Responsibilities

• Proactively develop, lead and drive the execution of Quality strategy and oversight for Bio Tissue.
• 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 Bio Tissue, 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.

• 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.

• Quality Management System (QMS)
• Environmental Monitoring
• Quality Assurance
• MDR/HHE reporting
• Change Control
• CAPA processes
• Budget preparation
• Fiscal management
• Regulatory data presentation
• Quality policies development

• Strategic thinking
• Interpersonal skills
• Advisory skills
• Written communication
• Verbal communication
• Analytical skills
• Leadership skills
• Organizational management
• Mentorship
• Conflict resolution

• Bachelor’s degree
• Master’s degree
• Certified Quality Auditor (CQA)