Gelesis is developing a novel hydrogel platform technology to treat overweight and obesity and chronic diseases related to the GI pathway. Gelesis’ proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of certain chronic diseases. In April 2019, Gelesis received FDA clearance for its lead product candidate, Plenity™, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Plenity is currently available in limited supply in the U.S. Additionally, Gelesis is developing its second investigational candidate, Gelesis200, a hydrogel optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics based on the Gelesis platform technology are also being advanced in other GI inflammatory conditions, such as non-alcoholic steatohepatitis (NASH) and Chronic Idiopathic Constipation (CIC).
Gelesis was also named one of Fast Company’s Most Innovative Companies for 2020.
The Gelesis executive and advisory team includes some of the world’s leading experts in obesity, materials science, chronic disease research, and commercialization. Gelesis was co-founded by PureTech Health (LSE: PRTC). For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.
Manager/ Sr Manager; Quality Assurance
Reporting directly to the Sr. Director of RA/QA, the Manager of Quality Assurance leads and supports the development and implementation of the Gelesis quality management system and compliance programs. Additionally, this position will assure all aspects of the Gelesis quality system are in conformance with customer, international and domestic requirements. This role manages multiple quality system functions, including but not limited to: Supplier Quality Management, Corrective and Preventive Actions (CAPA, SCAR); Design Assurance and Risk Management; Quality Improvement Program; Quality Planning; Quality Systems Metrics and Trending of Key Performance Indicators, Internal and External auditing programs.
Develop, implement and maintain quality assurance processes and activities to ensure that the company’s operation and products are in compliance with applicable quality standards and requirements, including 21 CFR 820, ISO 13485, EU MDR.
Manage the supplier qualification and monitoring program to ensure that product and services meet specified requirements.
Establish Design Assurance Processes to ensure that the company’s development activities follow design control process and products meet customer needs and regulatory requirements.
In addition, the Quality Manager Role may expand into responsibilities to support the Regulatory Affairs department:
Gelesis is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, veteran status, or any other status protected under federal, state, or local law.
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