Aspen Neuroscience is seeking to add a Director, Quality Assurance to its team. This is a career growth role for a GMP Operations professional responsible for on-site day to day tactical support to GMP. As a key leader in the Quality organization, this person will help build the quality systems for GXP support. The ideal candidate has a “builder” mindset and a hands-on approach to ensuring a solid foundation for the quality function. This is a unique opportunity to grow with the company while bringing strategic thinking to ensure systems and processes are scalable with the business.
Duties and Responsibilities:
Responsible for the review of master batch records, executed batch records, and the management of process related Deviations, CAPAs, Change Control, and the maintenance of the lot genealogy system.
Develop and maintain a GMP compliant document control function with appropriate processes, procedures, and practices. Maintain/Manage Electronic Document Management System for Document Management
Implement/manage the corporate Training System and training records. Work with department heads to develop training curriculums for all GxP personnel
Develop and implement supplier management program. Establish an approved supplier list. Establish Quality Agreements with critical suppliers
Develop and implement internal and external audit program. In that, establish an annual schedule for internal and external audits. Ensure audit schedule is executed as planned and conduct audits as appropriate. Follow-up on audit observations until adequate closure
Perform trending and analysis as required and provide metrics to quality management as requested in preparation for Quality Management Review
Establish and maintain a work environment that fosters open communication, collaboration, integration, and teamwork
Stay abreast of changes in applicable regulations, directive and guidelines and determine its impact on company programs
Complete other duties and tasks as required
Education and Experience:
Bachelor’s degree in health science or medical field or equivalent
8+ years of experience in the pharmaceutical or biotechnology industry
4+ years of experience in conducting internal and external audits
Proficient knowledge in cGMP environment in pharmaceuticals / biologics
Experience in managing the QA function, including leading a team of 2-5 professionals
Knowledge of regulations and standards affecting Pharmaceuticals, and Biologics.
Experience with GMP/GCP/ICH standards and regulatory guidance documents
Summit for Stem Cell was founded in 2011 because of a desire from Parkinson patients to fund a stem cell-based therapy for their disease. Summit started as a small group of friends raising money for a cause they believed in and grew into a large organization with supporters all over the world. Summit funded the work in Jeanne Loring’s lab at The Scripps Research Institute to develop an autologous neuron replacement program. After years of successfully supporting and promoting this brilliant body of science, Summit helped found Aspen Neuroscience, Inc. in late 2018. The iPSC-based therapy has been transferred to Aspen Neuroscience, Inc. and is now on an accelerated path to begin clinical trials.