Vice President, Quality

About the Role

The Vice President of Quality will proactively develop, lead, and drive the execution of Quality strategy and oversight for BioTissue. This position is responsible for leading the development, management, and continual improvement of the Quality Management System (QMS), ensuring compliance with regulatory requirements in the tissue processing, device, and biologics products environment. This leadership role involves strategic planning, decision-making, and team development, with interactions across internal business units and external regulatory authorities and business partners.

Responsibilities

• Serve as a key leader at BioTissue, collaborating to ensure QA/QC objectives align with the company’s operational and regulatory goals.
• Lead and mentor the Quality organization, ensuring accountability and clear cross-functional communication.
• Oversee the Quality Control function, including Environmental Monitoring and Quality Assurance activities.
• Apply knowledge of FDA regulations, GMP, GCP, GXP, and ISO Standards.
• Provide strategic leadership for the company’s Quality Management System (QMS), facilitating management reviews to monitor performance and drive continuous improvement.
• Support personnel with MDR/HHE reporting, Change Control, and CAPA processes.
• Set and maintain regulatory policies and quality standards for all quality systems, ensuring global compliance.
• Drive QMS execution through programs, policies, and functions that support corporate and product quality.
• Collaborate cross-functionally on strategy development, risk assessments, and implementation of quality principles and regulatory requirements.
• Develop and execute quality design and strategy for new product development, changes, and improvements.
• Analyze complex situations and propose practical solutions.
• Develop and manage a high-performance team focused on accountability and exceeding expectations.

Qualifications

• Bachelor’s degree in a related field (required).
• Master’s degree in a related field (preferred).
• Certified Quality Auditor (CQA) (preferred).
• Minimum of 15 years of experience in quality within the biotech, medical device, and pharmaceutical industry (preferred).

Skills

• Proven track record of leading Quality programs in large organizations.
• Strategic thinker with strong interpersonal and advisory skills for C-suite collaboration.
• Highly motivated with excellent written and verbal communication, analytical, and leadership skills.
• Ability to work under pressure and manage organizational tasks effectively.
• High integrity and ethics.
• Ability to develop and present regulatory and quality data and strategies.
• Skilled in budget preparation and fiscal management.
• Advanced knowledge of medical principles, methods, and procedures.
• Strong mentorship, people management, and project management skills.
• Working knowledge of conflict resolution and mediation principles.

Physical Requirements

Sedentary work that generally requires sitting and/or standing.