Sr./Director of Quality Assurance (GMP)

Company: Amplifybio, LLC
Location: West Jefferson
Posted on: March 20, 2023

Job Description:

Job Description:

Job Description Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! AmplifyBio is a company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities, and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates and soon to launch facility in New Albany, OH. The platforms and domain expertise at our New Albany site will fill the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream. We partner with our clients, leveraging state-of-the-art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial. When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees. AmplifyBio's next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in New Albany, OH. AmplifyBio is seeking to hire a Sr./Director of Quality Assurance (GMP) to join our growing team!!! The Dr./Director of Quality Assurance (GMP) will lead in developing and implementing quality systems for our GMP manufacturing/hoteling facility and personalized product development operations. Our Sr./Director of QA (GMP) must be able to assess projects from a QA standpoint using a broad understanding of the FDA and international requirements relevant to the production and release of cell therapy products and other biological products. This individual must be able to develop and implement the quality strategy for the site. The Sr./Director of QA (GMP) will be a member of cross-functional project teams and the liaison with FDA as well as business partners and suppliers in quality matters. The director ensures budgets, schedules and performance requirements are met. What You Will Do Here:Responsible for setting up quality systems for a multi-client GMP manufacturing/hoteling facility.Represent QA on project teams and in joint alliances as required. Direct all aspects of quality support and strategy for the project team on the designated product (s).Lead, facilitate, and coordinate quality meetings for the assigned project. Responsible for FDA liaison during audits.Initiate and update quality strategic plans for the projects and coordinate with the project leader for incorporation into a product development plan. Assess pros, cons and risks of the various strategic options and communicate to the project team and management.Direct development, initiation and maintenance of all quality systems in support of the product(s).Review and approve all documents used requiring a quality assessment (including protocols and reports).Ensure the project team objectives and timelines are supported by quality deliverables.Keep abreast of all pertinent laws, regulations and guidance relevant to specific product areas.Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.Coordinate with consultants and contractors as required.Manage, train and direct QA staff and managers reporting to the director. We Would Love to Hear from You If:At least 10 years US Quality Assurance experience and at least 12 years total biologics industry experience.Experience with a start-up company in Pre-IND phase and early phase product development is preferred.Minimum of BS in a relevant scientific discipline.Broad understanding of drug development.Competency in FDA/International GMP requirements is essential. Global experience a plus.Excellent verbal and written skills.Flexible mindset and ability to multitask. At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone - including women, people of color, individuals with disabilities and those in the LGBTQIA+ community - to apply for our available positions, even if they don't necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do. AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required. Why You Will Love Working Here: We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!Competitive Compensation PackageWe take work-life balance seriously and we back it up with an UNLIMITED PTO policy.Life and AD&D insuranceSupplemental insuranceLiveHealth OnlineSmart Shopper (helps you shop for better medical care and earn cash rewards while you save)Generous paid parental leaveWellness and Self-Care Programs401(k) matchTuition ReimbursementEAP/work-life support systemA fun work environment where everyone's voice matters.We are just getting started! More benefits on the way!An Opportunity to Change the World!!! PI207821312

Keywords: Amplifybio, LLC, Columbus , Sr./Director of Quality Assurance (GMP), Executive , West Jefferson, Ohio