Senior Director/Director, Clinical Quality Assurance

Company Overview

At Corbus we are committed to connecting innovation to purpose. We are bringing new insights to the fields of biology, with the aim of improving outcomes for cancer patients. We are committed to the concept of precision medicine, even in the field of immune oncology. Taking advantage of the evolution of multi-omic platforms to create deeper resolution as to the mechanism of action of our emerging medicines. We are creating a complementary pipeline balanced for both risk and speed.

Corbus is a precision oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin 4-on cancer cells to release a cytotoxic payload and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Corbus Culture

Our passion. Our purpose. At Corbus, it starts at our core.

We look for committed talent. Our people are brilliant, they break barriers and their contributions are not defined by title or role. Corbus recognizes that it is our diversity of experiences that make us valuable and Corbus welcomes transformative ideas from anyone. Corbus is a special place to share ideas and grow. We create flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what’s best for patients.

Corbus is a close-knit team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill.  At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. Corbus believes that fun along the way is also part of the equation that makes for high performing teams. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

What We Offer

Corbus offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package and work/life integration. Being part of the team allows you to become part of a growing organization that supports professional development while working together to meet the company goals.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.

Provide Quality Assurance oversight and compliance support for Corbus Clinical Developments Teams.

Key Responsibilities:

• Designs, implements and oversees a robust quality management program that ensures patient/study participant safety, data integrity, regulatory compliance as well as preclinical and CMC activities in support of the company’s drug development programs
•  Ensures effective process is put in place to ensure quality documentation and data are generated to support NDA/MAA filings.
• Ensures organizational inspection readiness at all times ensuring Corbus’s vendors and investigator sites are adequately supported for regulatory inspection.
• Provide liaison during inspections conducted by regulatory authorities including the preparation and hosting of the inspections and coordination of response
• Develop and mentor the Quality Assurance staff in support GxP activities
• Provide routine communication to the Senior Leadership Team  about the overall status of the Quality Management System
• Assure appropriate oversight of the Computer Software Validation program

• Assure appropriate oversight of the Vendor Qualification Program

Qualifications:

• BS degree in scientific field with 8+ years’ experience in biotech, pharma or CRO drug development
• Full understanding of GCP, GLP and GMP regulations and regulatory compliance guidelines
• Strong leadership and communication skills
• Ability to think strategically and to assist in the development of pragmatic and scalable QA processes that are adaptable to a growing company
• Ability to represent the company in regulatory audits, coordinating responses with legal, clinical development, and outside vendors where applicable
• Full and current knowledge of quality assurance best practices in a bio- pharmaceutical clinical environment.

All your information will be kept confidential according to EEO guidelines.