Tariffville, CT or Boston area
Join us in our mission to defeat diseases by applying your skills to real-world biomedical problems. Metrum Research Group is seeking a full-time Quality Manager in our Tariffville, CT or Boston area office to carry out a variety of operational responsibilities. In this role, you will help support the operations of a global leading company in biomedical modeling & simulation with the mission of improving health and defeating diseases.
As the Quality Manager, you will deliver technically robust and GxP compliant computerized systems and software development projects that withstand audits, both internal and external. The Quality Manager is expected to have working-level knowledge of Software Development and Qualification management and supporting infrastructure at the enterprise and local levels, including associated quality systems (i.e., change management, exception management, risk management, etc).
This role is responsible for ensuring practices are consistent with the requirements and expectations set forth within the governing internal Quality Management System and to be the main point of contact for external partner quality audits and inspections as a Quality representative.
- Perform and support all quality related activities associated with computerized systems, including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc.
- Ensure the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to the industry as well as internal expectations.
- Represent Quality on cross-functional teams in support of SDLC activities for GxP applications.
- Support internal and external audits as the Quality point of contact.
- Drive the deployment of new or modified GxP systems through review and approval of life cycle deliverables in compliance with the governing regulations and procedures.
- Organize, edit and generally maintain various internal quality documentation.
- Verify and document that defined processes have been followed for key workflows.
- Serve as main internal point of contact for day-to-day quality assurance tasks.
- Facilitate electronic signatures of documents and contracts.
- Hands-on experience in a quality role supporting the implementation of computerized systems within a GxP environment.
- Ability to interpret regulatory guidance and internal policies and procedures into executable and defendable lifecycle documentation.
- Depth of understanding of respective regulations governing computer systems and controls such as FDA’s 21 CFR Part 11 and GDPR.
- Understanding of risk-based methodologies as it relates to qualification and validation.
- Knowledge of underlying infrastructure requirements supporting GxP systems.
- General knowledge of SaaS, cloud computing, etc. and the associated key compliance components.
- Ability to complete tasks independently and with limited oversight.
Education and Experience
- 7-10 years experience in a quality role.
- Experience in a regulated industry is strongly preferred.
- Background in Lifesciences and/or Pharma/Biotech industries preferred.
- Experience in quality systems for software development and computing infrastructure is highly desirable.
- Bachelor’s Degree. Preferred emphasis in Engineering, Life Sciences, or IT related discipline.
- Ability to easily learn web-based software and communication tools with little formal instruction.
- Fluency with Google Suite or MS Office. Proficiency using Mac OS preferred.
About Metrum Research Group
Metrum Research Group is a leading provider of biomedical modeling and simulation services in the U.S.A. and internationally. Founded in 2004, Metrum Research Group has worked with over 150 clients on more than 475 projects. Our experience spans R&D efforts for small molecule pharmaceuticals, biologic therapeutics, diagnostics, and medical device/drug-device combinations, across multiple therapeutic areas. Metrum Research Group is an equal opportunity employer.