The Vice President of Quality Assurance/Quality Control will represent the senior advisor and leader on all quality issues. This individual, who will report to the Senior Vice President of Technical Operations, will be responsible for creating and implementing quality assurance and quality control systems and processes for cell and gene therapy products being manufactured by AavantiBio. This position will also be responsible for all Quality Control responsibilities regarding testing and release of these products as well as being responsible for the quality levels of raw materials and components sourced from external manufacturers. This role will collaborate across functions to improve quality processes and manufacturing ability of products, and will identify any risks on quality-related manufacturing problems.
· Full-time salary position with the opportunity for annual bonuses and participation in the Equity Incentive Plan. Benefits include high-quality health insurance plans including both gold and platinum Blue Cross Blue Shield plans, for which AavantiBio pays a competitive 85% of the health insurance premiums for our employees and their families. In addition to health insurance, we have put in place flexible spending accounts and other benefits for our employees, including dental, vision, short- and long-term disability, group life insurance, AFLAC, and more. To assist our employees with their retirement planning, AavantiBio offers a safe-harbor 401(k) plan with a generous 6% company match.
Responsibilities – Including but not limited to:
- · Create and implement a Quality Management System and the Quality organization needed to execute it.
- · Assess and provide recommendations to senior leadership on Quality systems and equipment to be purchased and implemented.
- · Will serve as the key liaison on Quality matters with all functions.
- · Implement best practices with respect to aseptic biologic manufacturing.
- · Oversee all GMP quality activities and ensures they are governed through key performance metrics and a quality review system.
- · Develop, in conjunction with all stakeholder groups, a Quality Manual and Master Quality Plan for the manufacturing site.
- · Provide leadership on quality policies and practices, while working in collaboration with multiple functions at AavantiBio.
- · Assure that finished products conform to government and company standards and regulatory approvals for clinical and commercial products.
- · Lead a customer focus approach in the organization so that all functions view the quality organization as a proactive collaborator and partner in achieving goals.
- · Provide the leadership to assure the preparation of appropriate documentation for filing with regulatory bodies.
- · Develop a quality organization and staff to implement and maintain compliance with cGMP and all health agency requirements.
- · Provide the overall leadership with respect to recruiting, training, developing, and supervising staff to accomplish quality compliance and goals.
- · Responsible for establishing department budgets and managing expenditures appropriately.
- · Aid and collaborate on changing job responsibilities with team members as AavantiBio grows and achieves success.
Qualifications – Experience, Knowledge & Skills:
- · 15+ years’ experience as a biopharmaceutical quality leader.
- · 10+ years’ experience working with cell and gene therapy products a strong plus.
- · BA/BS degree in related health science. An advanced scientific degree is highly desirable.
- · Relevant knowledge and experience base working with research and development and manufacturing groups on quality issues is required.
- · A strong experience base on global GMP, QA, and QC issues pertaining to biologics is required.
- · Expertise in aseptic manufacturing is required.
- · In-depth knowledge of FDA, EU and International regulations, EU, and US compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications, and cGMP.
- · Demonstrated, hands-on approach to building a successful quality organization in a startup environment preferred.
- · Understanding of AAV viral vector manufacturing preferred.
- · Excellent communication, leadership, and collaboration skills.
- · Flexible and able to adapt to company growth and evolving responsibilities.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
About the company
11-50 employees - Biotechnology
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease.
AavantiBio is headquartered in Cambridge, MA with an additional location in Gainesville, FL. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
Developing genetic treatments for rare diseases is inspiring but challenging work and it takes dedication and courage which will make a meaningful impact on those who suffer from rare diseases. At AavantiBio, we will push each other to perform at our very best and build a company that not only our employees are proud of, but also the rare disease community, because everyone knows we are trying to make a difference in patients’ lives.
Come join our team!