Vice President, Quality Systems & Regulatory Affairs

Description:

Job purpose

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.

Duties and 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

Requirements:

Qualifications

1. A minimum of 10+ years Tissue Bank quality leadership experience with 6 years management experience is required.
2. Background in quality leadership with musculoskeletal tissue is highly preferred.
3. Ability to build high performing teams while implementing new processes and procedures to enhance organizational efficiencies.
4. Demonstrated ability for process improvement and to create and implement simple, compliant systems in diverse areas of quality.
5. Must be a positive change agent and able to adapt in a dynamic environment.
6. Experience with development, implementation, and optimization of IT tools to deliver business outcomes.
7. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
8. AATB Certified Tissue Bank Specialist (CTBS) is preferred. Lean six-sigma belt / demonstrated process improvement experience is also strongly preferred.
9. Skilled in successfully overseeing and managing FDA and AATB notified body inspections.
10. Proficient in the tissue banking industry including Production QA/QC, clean rooms, sterile processing, and sterilization dose audits.
11. 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.
12. Bachelor’s degree Biology, Chemistry, Engineering, or related field is required. A master’s degree in a related field is ideal.

Working conditions

Office, processing plant work, travel by air, train, & 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

Nothing in this job description restricts management’s right to assign or reassign duties and

responsibilities to this job any time.

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 Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.