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
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