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Senior Director, R&D Quality Assurance (GCP-GLP-GvP)

Waltham, MAPosted 1 months ago
Full-timeonsite

Job Description

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
 

We are seeking a Senior Director, R&D Quality (GCP–GLP–GvP) is a key leader within Crescent’s Quality organization, responsible for providing strategic and hands-on Quality Assurance leadership for clinical, nonclinical, and pharmacovigilance activities across Crescent’s development programs. You partner closely with Clinical Development, Clinical Operations, Nonclinical Development, Pharmacovigilance, Regulatory, and external partners to ensure phase-appropriate compliance with global GxP regulations, robust data integrity, and continuous inspection readiness within a highly outsourced development model.

Please note, this person must be local to the Waltham, MA office.
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
 

We are seeking a Senior Director, R&D Quality (GCP–GLP–GvP) is a key leader within Crescent’s Quality organization, responsible for providing strategic and hands-on Quality Assurance leadership for clinical, nonclinical, and pharmacovigilance activities across Crescent’s development programs. You partner closely with Clinical Development, Clinical Operations, Nonclinical Development, Pharmacovigilance, Regulatory, and external partners to ensure phase-appropriate compliance with global GxP regulations, robust data integrity, and continuous inspection readiness within a highly outsourced development model.

Please note, this person must be local to the Waltham, MA office.

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. 

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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Senior Director, R&D Quality Assurance (GCP-GLP-GvP) at Crescent Biopharma | Renata