Over the next 10 years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy will dramatically change how we treat cancer and other major illnesses. Biofuels and biomaterials will transform the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology will produce sustainable and ethical food. Benchling’s mission is to accelerate the research that propels us towards this future, and magnify its impact, through modern software.
Every day, scientists around the world use Benchling in their efforts to solve humanity's most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research.
Benchling was founded by a team of MIT graduates and has raised funding from Benchmark, Andreessen Horowitz, Thrive Capital, and Y Combinator. Our customers include pharmaceutical giants, leading biotechs, and the world's most renowned research institutes.
As a Quality Systems Manager you will have a hands-on role helping to establish our Quality Management System for Benchling. You'll work with agile teams to implement new & existing Standard Operating Procedures by which we design, verify, and validate our products, manage risk and execute as an organization. You'll work collaboratively across functional areas in the development, maintenance, and continuous improvement of Benchling's quality processes.
- Manage quality system processes such as Change Control, Document Control, Regulatory Assessments and CAPA in support of Benchling’s GxP offering.
- Author and revise standard operating procedures and work instructions. Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines.
- Ensure policies, procedures and compliance documentation conforms to applicable standards and guidelines through periodic review and internal audits.
- Generate metrics, reporting, and documentation in support of a continuously improving QMS in alignment with FDA and ISO guidelines.
- Provide quality oversight for qualification and validation activities including protocol generation, execution, and final report documentation. Approve IQ/OQ/PQ protocol and reports.
- Establish and maintain formal document management and change control systems for GXP related activities. Review and approve change controls related to the product upgrades, system changes and documentation changes.
- Design, implement, and maintain the nonconformance and CAPA management system.
- Collaborate with other departments for investigations and determination of root cause.
- Oversee the execution and completion of CA or PA activities.
- Identify opportunities for improvement, and drives continuous improvement initiatives.
- Support external audits in support of customers’ GxP compliance as needed.
- Mentor junior team members in validation and quality teams.
- B.S. in Life Sciences or Engineering with 9+ years of Life Sciences Quality and Compliance experience
- Strong understanding of regulatory requirements around FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GLP and GMP regulations as well as ISO 9001 QMS requirements
- Experience working with lab systems (ELN, LIMS, SDMS) and process in a GxP environment is highly desirable
- Have hands-on working knowledge and passion for modern quality tools and agile approaches
- Ability to thrive in a fast-paced dynamic environment with the ability to maintain objective and autonomous as it relates to quality and compliance
- Experience as a Quality Systems Manager at a medical, biotech, pharma or equivalent
- Empower through information. We explain the “why” behind every decision, unless there are highly sensitive circumstances. We're honest about how we're doing, especially in difficult times. We believe that sharing information builds trust and enables better decision-making.
- Rely on tenacity. Hard work is one of the greatest factors to determine success and is fully under our control. We must make the most of every day by bringing the highest level of determination. Dreaming big is not enough.
- Raise the bar. Pushing ourselves and others to improve will be uncomfortable and at times result in failure. However, it's critical to our success. We're dedicated to creating a place where everyone feels challenged to improve.
- Build a lever. We choose to build tools and infrastructure that will help others make world-changing innovations. There's less glory in it, but in the words of Archimedes, "Give me a lever long enough and a fulcrum on which to place it, and I shall move the world."
PERKS AND BENEFITS
- Work with a talented yet humble team
- Competitive compensation & equity package
- Monthly health & wellness stipend
- Medical, dental, and vision insurance
- Weekly virtual social events, and annual company retreats
- *$1,000 work-from-home stipend
*In following best practices and safety protocols, all Benchling employees are expected to work remotely until we are further advised that it is safe for employees to resume work in their respective office locations. To support remote work conditions, Benchling provides each employee a one-time stipend of $1,000 upon commencing employment, and additional discounted employee purchase plans for home-office equipment.