Vice President, Quality Systems & Regulatory Affairs

Description

The Vice President of Quality Assurance & Regulatory Affairs will be responsible for leading all aspects of quality for VIVEX, the. 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 quality culture of excellence in a fast-growing company in human tissue-based products (musculoskeletal and amniotic).

The individual we are seeking will manage Q&R for a state-of-the-art, GTP compliant manufacturing and R&D facility totaling approximately 100K square feet with multiple clean rooms and donor bays. The Vice President will employ an efficient, flexible, and compliant quality department. S/he will implement improved processes & procedures ensuring its products continue to be safe and effective, in addition to the development and release of new products, as the company continues to scale.

The Vice President of Quality Assurance & Regulatory Affairs will constantly strive for continuous quality improvement, while collaborating with cross functional leaders in all departments, keeping the company ahead of the curve. The Vice President of Quality Assurance & Regulatory Affairs

will lead a sizable team including director/managers in Quality Assurance Operations, Validations 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 those of the Food and Drug Administration (FDA) and the American Association of Tissue Banks’ standards (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 hosting audits by regulatory bodies and state/local agencies. Follow up to ensure that any 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 cGMP's, company policies, procedures and guidelines, regulatory requirements, etc.
• Oversee the validation and verification of clean rooms, equipment, and other tasks essential to manufacturing quality products.
• As a proactive leader, collaborate closely with the operations/R&D, evaluating risk/benefits for operational efficiencies while keeping in compliance with regulatory bodies.
• Works closely with corporate functions such as Operations, R&D Supply Chain, Commercial Teams, Finance. This individual will educate the team, working to build out the Quality group in line with company objectives and keeping the company compliant.
• Budget management leadership and resource/planning allocation responsibility.
• Responsibilities include planning, assigning, and directing work; appraising performance,
• addressing complaints and resolving problems in conjunction with department heads. Facilitate department reviews and team meetings. Complete annual department performance and salary reviews. Recruits, hires, and trains department staff as required.
• Performs other related duties as assigned