Evelo Biosciences, Inc. (Nasdaq: EVLO) a biotechnology company developing a new modality of orally delivered, systemically acting biologics that could disrupt the industry is looking for a highly motivated individual who is energized by the prospect of working in a clinical stage company, has a strong desire to learn, and wishes to be an integral member of an interdisciplinary team.
As the Quality Systems & Training Manager, you will be responsible for the creation and maintenance of key Quality Management systems including supplier management, deviations, investigations, CAPAs, change controls, GXP training, risk management and auditing/regulatory inspections. The candidate will establish and implement training program for all employees supporting GXP operations. In this position, you will ensure compliance with applicable regulations in support of GXP compliant programs.
This position is based in Cambridge, MA.
Duties and Responsibilities
- Establish and maintain an electronic document management system compliant with regulatory, and quality requirements.
- Build and manage the quality systems around quality events including deviations, investigations, CAPAs, laboratory investigations, etc.
- Interact with all departments to develop and implement functional documents as part of functional SOPs initiative (or a Quality Improvement Plan project).
- Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
- Establish and maintain records management system including secure storage, retrieval, retention, and destruction.
- Ensure controlled documents are periodically reviewed for relevance and accuracy in line with internal processes and GXP.
- Evaluate capabilities of the electronic management system and assess if improvements are necessary to maintain compliance.
- Conduct risk assessments to support quality management systems and justify quality related decisions.
- Manage and deepen the quality supplier management processes including supplier qualification, approved supplier list, quality agreements, supplier change notifications, auditing and supplier corrective action requests, etc.
- Establish and maintain records management system including secure storage, retrieval, retention and destruction.
- Quality Metrics – participate in the development and tracking of Key Performance Indicators (KPIs), and collation of metrics as part of QMS improvement.
- Contribute to the development and implementation of the corporate strategy for cGMP compliance.
- Manage projects in a cross functional environment that drives quality compliance and continuous improvement.
- Assist in the maintenance of regulatory documents, as necessary.
- Develop and execute GXP training strategy including working with stakeholders to determine needs and provide appropriate training to meet those learning needs.
- Develop training materials, in collaboration with SMEs, for existing and new employees ensuring all aspects of job responsibilities and expectations are met to reduce risk, improve efficiency and compliance.
- Work as a training and competency expert with various teams and clients developing training material via e-Learning, video, and other presentations.
- Provide new hires an introduction to Quality System as part of new employee orientation.
- Support internal, vendor and third-party audits, and regulatory agency inspections.
- Perform other duties as required.
- A minimum bachelor’s degree in a scientific discipline e.g., chemistry, pharmacy, biochemistry, biology, or related discipline required.
- Minimum 5 years of QA GMP / compliance experience in the biotech/pharmaceutical environment required.
- MS in chemistry, pharmacy, biochemistry, biology, or related discipline preferred.
- Demonstrated strong understanding of US (FDA) cGMPs and knowledge of EU GMPs.
- Experience in hosting GMP regulatory inspections desirable.
- Experience in the operational quality management of contract manufacturing organizations (CMO) for production of drug substance and drug products.
- Attention to detail, time management, and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines with minimal oversight.
- Strong interpersonal communication and soft skills, ability to work in team environment, strong organizational and basic project management skills.
- Experience in a start-up environment, requiring flexibility along with the ability to seek out and quickly assimilate new information would be a plus.
- Experience with Electronic Document Management System / Learning Management System.