Senior Director, GCP Quality Assurance and Head of Quality Assurance
Job ID: 2
Type: Regular Full-Time
# of Openings: 1
Category: Research & Development
With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Nuvalent is funded by Deerfield Management.
The Senior Director, GCP Quality Assurance and Head of Quality Assurance is responsible for the strategic development and execution of the Company’s quality assurance program and is accountable for the execution and administration of the GXP Quality Systems to support GMP, GLP, and GCP compliance in accordance with ICH guidelines. In this role you will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and provide leadership to the organization on global quality matters.
Reporting to the VP of Pharmaceutical Development, this individual has primary responsibility for oversight of GCP as well as GPvP and GCLP activities at Nuvalent, its contract research organizations, and Investigator Sites to ensure that outsourced third parties are compliant and prepared for Sponsor and Regulatory Inspections. This person is responsible for ensuring that the appropriate quality processes and systems are in place and performed to protect the rights, safety, and welfare of our clinical patients. This individual oversees, assesses, and directly works to continuously improve GCP quality processes and to support GCP compliance at Nuvalent and ensure high quality execution of clinical trials from first in human through commercial marketing authorization. Past the GCP role, this person manages cross functional relationships with internal and external stakeholders and oversees the team that represents Quality at Nuvalent.
CORE ACCOUNTABILITIES :
The successful candidate will lead the company through the following areas/interactions:
REQUIRED KNOWLEDGE AND ABILITIES:
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
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