Vivex Biologics · 1 month ago
Vice President, Quality Systems & Regulatory Affairs
Miami,FL,US
Full-time
Onsite
Director/Executive
10+ years expVivex Biologics is a company focused on human tissue-based products, and they are seeking a Vice President of Quality Assurance & Regulatory Affairs to lead their quality initiatives. This role involves ensuring compliance with regulatory bodies, fostering a quality culture, and managing a team responsible for quality operations and regulatory submissions.
BiotechnologyHealth CareTherapeutics
Responsibilities
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
Qualification
Required
A minimum of 10+ years Tissue Bank quality leadership experience with 6 years management experience is required
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
Must be a positive change agent and 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
Skilled in successfully overseeing and managing FDA and AATB notified body inspections
Proficient in the tissue banking industry including Production QA/QC, clean rooms, sterile processing, and sterilization dose audits
Knowledge of and implementation of cGMP-compliant quality environment supporting processing tissue or cell-based materials for research and clinical studies for future FDA regulated biologics or devices
Bachelor's degree Biology, Chemistry, Engineering, or related field is required
Preferred
Background in quality leadership with musculoskeletal tissue is highly preferred
AATB Certified Tissue Bank Specialist (CTBS) is preferred
Lean six-sigma belt / demonstrated process improvement experience is also strongly preferred
A master's degree in a related field is ideal
Company
Vivex Biologics
VIVEX Biologics' mission is to provide regenerative product solutions that help patients suffering from musculoskeletal injuries and wounds.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Agle
President & COO Legacy Donor Services Foundation
Tim Ganey
Chief Science Officer
Recent News
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