Imagine a future where a simple urine test can detect deadly diseases before they get out of control. A future when diseases can be intercepted and people don’t become patients. At Glympse Bio, we are working to turn this vision into a reality. Take a glimpse into that future, where we are taking a glimpse inside the body.
Glympse Bio is looking for an experienced and highly motivated Quality Lead to contribute towards the development of activity-based sensors in nonalcoholic Steatohepatitis (NASH), liver fibrosis, and liver cancer. This role will report directly to the Chief Development Officer, and will be directly responsible for all aspects of Glympse Bio’s quality strategy. This position will be based in our Cambridge, Massachusetts headquarters.
Responsibilities and Duties
- Design, implement, manage and continuously improve Glympse’s Quality Management System.
- Establish an effective network of consultants/auditors, and other resources to assist in ensuring all development activities performed by Glympse’s staff, or on behalf of Glympse by Third Party Providers, are done with patient safety, data integrity and quality system and regulatory compliance in mind.
- Lead the quality system interactions between Glympse and its suppliers and guide the quality organizations within the company’s CROs, CMOs and other outsourced and supplier relationships to achieve company goals. Maximize the use of external resources (CRO's, CMO's, etc.) and integration with internal domain expertise.
- Ensure GXP compliance.
- Maintain quality system and clinical records in a manner that will allow their use in the various regulatory submissions that will be required for Glympse’s products.
Qualifications and Skills
- A minimum of 10 years of experience in the Medical Device/Drug industry.
- Demonstrated success in the creation and management of a Quality System compliant with FDA Part 4 and ISO 13485 requirements.
- BS/MS/PhD in a science related field and/or have extensive Medical Device/Drug industry experience.
- Knowledge of In-Vitro Diagnostic (IVD) testing required, knowledge of UPLC/MS IVD measurements or Clinical Test Lab operations, preferred.
- Proven ability to lead key initiatives and motivate combined internal / external teams to work collaboratively to achieve objectives.
- Excellent project management skills.
- Ability to present effectively with internal and external audiences.
- Ability to make well founded recommendations to senior management.
- Demonstrated ability to build a highly productive, lean team that can effectively leverage external resources to achieve organizational and project objectives.
- A team player who collaborates cross-functionally, exercises influence at senior levels, and builds alignment around goals and objectives.
- Highly articulate and fluid communicator in both individual and group settings.
- Must be authorized to work for any United States employer.