Senior Manager - GCP, GVP, GLP Quality

2 days ago

Apply Now

Receive Emails with Similar Jobs

Cullinan Oncology

WebsiteLinkedInAll Job Openings

Oncology

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

💰 $10M Post-IPO Equity on 2022-03

Description

• Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. • We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. • Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. • Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications. • We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. • With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. • The Senior Manager of GCP/GVP/GLP Quality is a responsible member of the R&D GxP QA team and provides QA expertise, consultation and oversight with regard to GxP activities for branded biotechnology and pharmaceutical development products. • The Sr Manager of GCP/GLP/GVP QA will assist in the development and maturation of a Phase appropriate Quality Management System (QMS). This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate. • The incumbent will support, conduct and/or interpret internal and external GCP/GLP/GVP audits with a focus on risk mitigation and management as well as process improvement. • The Sr Manager of GCP/GLP/GVP will also be part of cross functional NDA/BLA filing diligence, inspection readiness and inspection support.

Requirements

• Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations, and ICH guidelines gained through direct experience in the drug development process gained through working for a branded biotech or pharmaceutical company. • Working knowledge of supporting preparation, submission, and pre-approval activities, specifically in relation to GCP, GLP and PV Quality, for global regulatory filings for branded pharmaceutical/biotech products. • Ability to influence others as part of a collaborative team and negotiate effective solutions to complex problems; strong interpersonal and social skills. • Minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training. • Bachelor's degree in a relevant field, such as Life Sciences or Healthcare required. Advanced degree preferred. • Authorization to work in the US for a company. • Candidates located within commuting distance of the Cullinan Cambridge MA office preferred. Candidates on East Coast or Central US considered. • Ability to travel up to 25%.