Vice President, Quality Systems & Regulatory Affairs

Vice President, Quality Systems & Regulatory Affairs
VIVEX BIOLOGICS INC
• Miami, FL, US

The Vice President of Quality Assurance & Regulatory Affairs will be responsible for leading all aspects of quality for VIVEX. S/he will work with the quality teams to comply with all state and regulatory bodies including the FDA, AATB, and notified bodies. This individual will be a seasoned leader who will create and foster a culture of quality excellence in a fast‑growing company focused on human tissue‑based products (musculoskeletal and amniotic).

The Vice President will manage Q&R for a state‑of‑the‑art, GMP‑compliant manufacturing and R&D facility totaling approximately 100 k square feet with multiple clean rooms and donor bays. They will employ an efficient, flexible, and compliant quality department, implement improved processes & procedures, and oversee the development and release of new products as the company scales. The Vice President will constantly strive for continuous quality improvement while collaborating with cross‑functional leaders in all departments to keep the company ahead of the curve.

The Vice President will lead a sizable team, including director/managers in Quality Assurance Operations, Validation Engineering & QAE, Training & Document Control, Quality Control (Product Testing & Inspections), Regulatory Affairs (Submissions & Supplier Qualifications), Quality Assurance (QMS and Donor & Product Release), QC and Quality Engineering.

• Ensure compliance with all current federal, state, and/or local laws and/or regulations, including FDA, AATB, notified bodies, OSHA, state and local regulations, and ISO 9001; provide leadership in complying with Good Tissue Practices.
• Serve as the Company’s Quality Management Representative, preparing for hosting audits by regulatory bodies and state/local agencies; follow up to ensure findings are resolved through investigations and corrective actions in a timely manner.
• Develop strategies, metrics, processes, and systems to support strategic goals and operational priorities.
• Provide leadership and mentoring to directors, managers and staff, enhancing morale, performance, and employee retention.
• Develop and implement improvement initiatives and processes leading to operational efficiencies.
• Maintain a broad‑based expertise of cGMPs, company policies, procedures, regulatory requirements, and guidelines.
• Oversee the validation and verification of clean rooms, equipment, and other tasks essential to manufacturing quality products.
• Collaborate closely with Operations/R&D, evaluating risk/benefits for operational efficiencies while keeping in compliance with regulatory bodies.
• Work closely with corporate functions such as Operations, R&D Supply Chain, Commercial Teams, Finance; educate the team, build out the Quality group in line with company objectives, and keep the company compliant.
• Lead budget management and resource/planning allocation.
• Plan, assign, and direct work; appraise performance and address complaints and resolve problems in conjunction with department heads.
• Facilitate department reviews and team meetings; complete annual department performance and salary reviews.
• Recruit, hire, and train department staff as required.
• Perform other related duties as assigned.

• Minimum of 10+ years of Tissue Bank quality leadership experience with 6 years of management experience.
• Background in quality leadership with musculoskeletal tissue highly preferred.
• Ability to build high‑performing teams while implementing new processes and procedures to enhance organizational efficiencies.
• Demonstrated ability for process improvement and to create and implement simple, compliant systems in diverse areas of quality.
• Positive change agent able to adapt in a dynamic environment.
• Experience with development, implementation, and optimization of IT tools to deliver business outcomes.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• AATB Certified Tissue Bank Specialist (CTBS) preferred;
  Lean Six‑Sigma belt / demonstrated process improvement experience also strongly…