About Gelesis:

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, Plenityi, 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 Companyis 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

Job Summary:

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.

Responsibilities:
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.

• Author, review and approve QMS procedures that define a system of linked processes which produce the desired outcome. Establish effective change control.
• Identify quality data sources and use a risk-based approach to define the measurement and analysis methods to drive continuous improvement.
• Establish and monitor the internal audit program, perform internal audits.
• Administer the corrective and preventive action program
• Lead quality initiatives and remediation efforts to achieve quality goals
• Analyze quality data and report on QMS performance to support management reviews.
• Assist in readiness assessment and preparation for regulatory inspection

Manage the supplier qualification and monitoring program to ensure that product and services meet specified requirements.

• Select and qualify suppliers based on defined criteria and demonstrated capabilities
• liaise with suppliers and establish effective supplier relationship and communication
• Develop and maintain quality agreements with contract manufacturers, suppliers, and laboratories
• monitor supplier performance through quality data and supplier audits
• initiate supplier corrective actions and drive issue resolution to promote continuous process improvement

Establish Design Assurance Processes to ensure that the company's development activities follow design control process and products meet customer needs and regulatory requirements.

• Represent Quality Assurance in Development Teams and Design Reviews.
• Support the risk management process and integrate with post-market data analysis
• Review and approve product and process specifications
• Review and approve verification and validation protocols/reports to ensure compliance with defined specifications and regulatory requirements.

In addition, the Quality Manager Role may expand into responsibilities to support the Regulatory Affairs department:

• Identify and communicate regulatory requirements as design inputs to product development teams
• Review and author content for regulatory submissions, such as (de novo, 510k, Technical Files)
• Manage regulatory compliance, establishment registrations, device listings, UDI/GUDID listing, ISO certifications

Experience/Qualifications:

• Bachelor of Science Degree in a technical or life science discipline with 8-10 years of medical device or life sciences experience
• Working knowledge of relevant FDA and EU quality systems regulations, international standards and guidance.
• Experience implementing ISO 13485 quality management system.
• Experience working with CMOs and outside vendors required.
• Excellent judgment and ability to communicate complex issues in an understandable way.
• Outstanding communication skills (verbal and written).
• Ability to manage multiple projects in a fast-paced environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Experience with implementation of document management systems (Veeva, ComplianceQuest) is a plus
• Strong working knowledge with MS Office (Outlook/Teams/Word/Excel/PPT)
• Ability/flexibility to travel up to 25% ( once travel restrictions are lifted )

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.