Address
Form of workCorbus Culture:
Our passion. Our purpose. At Corbus, it starts at our core.
We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team 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.
About Corbus:
Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus' current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGF and an antibody drug conjugate targeting tumors expressing nectin-4. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.
General Description:
Provides Quality Assurance oversight and GxPs compliance support for all Corbus Product Development Teams (PDTs).
Responsibilities:
- Designs, implements and oversees a robust quality management system and process documentation 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 processes are put in place to ensure quality documentation and data are generated to support IND/NDA/MAA filings.
- Always ensures organizational inspection readiness, including support for Corbus's vendors and investigators, as applicable.
- Provide liaison during inspections conducted by regulatory authorities including the preparation and hosting of the inspections and coordination of response.
- Lead the investigations of quality issues and work with Corbus or vendor teams to develop effective corrective actions and preventative actions (CAPAs), ensuring that all CAPAs have been effective.
- 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
- Works with Corbus Product Development Teams (PDTs) to ensure compliance with GxPs, applicable regulations, Corbus SOPs and Policies, and best practices.
Qualifications and Experience:
- Bachelor's Degree in life sciences
- Professional Quality Assurance Qualifications preferred
- 10+ years' experience in biotech, pharma or CRO
- Full understanding on GxPs and regulatory compliance guidelines
- Current knowledge of Quality Assurance best practices in bio-pharmaceutical environment
- Experience of leading GxP audits
Qualities:
- Be a strong advocate for Quality within the Corbus, influencing thinking and execution of activities.
- Communicate well with internal and external stakeholders.
- Exhibit strategic thinking and develop pragmatic and scalable QA processes that are adaptable to a growing company.
- Represent the company in a professional manner in regulatory inspections, audits, and lead inspection response teams.
Location and Reporting Structure:
Hybrid 3 days onsite in Norwood Ma and 2 days remote. Reports to Head Of Operations.
Location and Reporting Structure:
- Hybrid 3 days onsite in Norwood Ma and 2 days remote.
- Reports to Head Of Operations.
