Vivex Biologics
Vice President, Quality Systems & Regulatory Affairs
Vivex Biologics, Miami, Florida, us, 33222
Vice President, Quality Systems & Regulatory Affairs
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Vice President, Quality Systems & Regulatory Affairs
role at
Vivex Biologics .
Job Purpose 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 quality culture of excellence in a fast‑growing company in human tissue‑based products (musculoskeletal and amniotic).
The Vice President 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. S/he will employ an efficient, flexible, and compliant quality department, implement improved processes & procedures ensuring its products continue to be safe and effective, and oversee 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 across all departments, keeping the company ahead of the curve.
Duties & Responsibilities
Ensure compliance with all current federal, state, and local laws and regulations, including FDA, AATB, OSHA, ISO 9001, and Good Tissue Practices.
Serve as the Company’s Quality Management Representative, preparing for audits by regulatory bodies and state/local agencies. Follow up to resolve findings 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 to enhance morale, performance and employee retention.
Develop and implement improvement initiatives and processes leading to operational efficiencies.
Maintain broad‑based expertise of cGMP, company policies, procedures and regulatory requirements.
Oversee validation and verification of clean rooms, equipment and other critical manufacturing quality tasks.
Collaborate closely with Operations/R&D to evaluate risk/benefits for operational efficiencies while remaining compliant with regulatory bodies.
Work closely with corporate functions such as Operations, R&D Supply Chain, Commercial Teams, Finance. Educate the team and build the Quality group in line with company objectives.
Budget management and resource/planning allocation responsibility.
Plan, assign and direct work; appraise performance; 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.
Qualifications
A minimum of 10+ years Tissue Bank quality leadership experience with at least 6 years of management experience.
Background in quality leadership with musculoskeletal tissue highly preferred.
Ability to build high performing teams and implement new processes and procedures to enhance organizational efficiencies.
Demonstrated process improvement ability and establishing simple, compliant systems.
Positive change agent, adaptable 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) is preferred; Lean Six Sigma belt / process improvement experience strongly preferred.
Skilled in 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 a 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 in Biology, Chemistry, Engineering or related field required; master’s degree preferred.
Working Conditions Office, processing plant work, travel by air, train and car.
Physical Requirements Sitting, standing, walking, bending, light lifting. Communicates verbally and in writing; observes employee actions and listens to employees and management.
Direct Reports Sr. Director Quality Systems
Equal Opportunity Employer Statement Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Vivex Biologics, Inc. complies with the Americans with Disabilities Act (ADA).
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Vice President, Quality Systems & Regulatory Affairs
role at
Vivex Biologics .
Job Purpose 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 quality culture of excellence in a fast‑growing company in human tissue‑based products (musculoskeletal and amniotic).
The Vice President 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. S/he will employ an efficient, flexible, and compliant quality department, implement improved processes & procedures ensuring its products continue to be safe and effective, and oversee 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 across all departments, keeping the company ahead of the curve.
Duties & Responsibilities
Ensure compliance with all current federal, state, and local laws and regulations, including FDA, AATB, OSHA, ISO 9001, and Good Tissue Practices.
Serve as the Company’s Quality Management Representative, preparing for audits by regulatory bodies and state/local agencies. Follow up to resolve findings 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 to enhance morale, performance and employee retention.
Develop and implement improvement initiatives and processes leading to operational efficiencies.
Maintain broad‑based expertise of cGMP, company policies, procedures and regulatory requirements.
Oversee validation and verification of clean rooms, equipment and other critical manufacturing quality tasks.
Collaborate closely with Operations/R&D to evaluate risk/benefits for operational efficiencies while remaining compliant with regulatory bodies.
Work closely with corporate functions such as Operations, R&D Supply Chain, Commercial Teams, Finance. Educate the team and build the Quality group in line with company objectives.
Budget management and resource/planning allocation responsibility.
Plan, assign and direct work; appraise performance; 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.
Qualifications
A minimum of 10+ years Tissue Bank quality leadership experience with at least 6 years of management experience.
Background in quality leadership with musculoskeletal tissue highly preferred.
Ability to build high performing teams and implement new processes and procedures to enhance organizational efficiencies.
Demonstrated process improvement ability and establishing simple, compliant systems.
Positive change agent, adaptable 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) is preferred; Lean Six Sigma belt / process improvement experience strongly preferred.
Skilled in 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 a 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 in Biology, Chemistry, Engineering or related field required; master’s degree preferred.
Working Conditions Office, processing plant work, travel by air, train and car.
Physical Requirements Sitting, standing, walking, bending, light lifting. Communicates verbally and in writing; observes employee actions and listens to employees and management.
Direct Reports Sr. Director Quality Systems
Equal Opportunity Employer Statement Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Vivex Biologics, Inc. complies with the Americans with Disabilities Act (ADA).
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