Position Summary
The Vice President of Quality will proactively develop, lead and drive the execution of Quality strategy and oversight for BioTissue. This position also has responsibility for leading the development, management and continual improvement of the Quality Management System (QMS).
Responsibilities include establishing and maintaining the quality system, developing quality policies and objectives, leading external and internal audits, complying with various regulatory requirements within the tissue processing environment, device and biologics products. This is a leadership position involving strategic planning / decision-making and team development. Interactions with other internal business units, and external regulatory authorities and business partners are required.
Essential Duties & Responsibilities
- Serve as a key leader at BioTissue, working collaboratively to ensure QA/QC objectives are met and aligned with the company’s operational and regulatory objectives.
- Lead and mentor the Quality organization, ensuring appropriate levels of accountability for decision making and clearly communicating cross functionally within the organization.
- Responsible for the Quality Control function as it pertains to Environmental Monitoring and Quality Assurance activities.
- Knowledge and experience with FDA regulations, GMP, GCP, GXP and ISO Standards.
- Responsible for strategic leadership of the company’s Quality Management System (QMS). Facilitate management review of QMS to monitor performance and create/support process enhancement initiatives to drive continuous improvement.
- 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 and ensure compliance with applicable regulations worldwide.
- Drive execution of QMS processes through programs, policies and functions that support corporate and product quality.
- Support specific departmental needs to maintain and improve QMS requirements for ongoing laboratory and other operational activities.
- Collaborate cross-functionally with internal departments on strategy development, risk assessments and implementation of quality principles and regulatory requirements.
- Support specific departmental needs to maintain and improve QMS requirements for ongoing laboratory and other operational activities.
- Develop and execute quality design and quality strategy for new product development, changes and improvements.
- Extensive ability to analyze complex situations and propose practical solutions.
- Ability to develop and manage a high-performance team focused on accountability and exceeding expectations.
- Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.
Skills & Abilities
Essential Duty Definition:
- 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.
Position Expertise/Qualifications
- 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.
Physical Requirements
- Sedentary work that generally requires sitting and/or standing