Apply on Employer Site

Priovant Therapeutics · 5 hours ago

Senior Associate/Manager, Quality

Durham, NC

Full-time

Onsite

Senior Level

6+ years exp

Priovant Therapeutics is committed to developing therapies that address high unmet need in autoimmune disease, and they are seeking a Senior Associate/Manager, Quality to ensure complete and compliant documentation of clinical study activities. The role involves developing Quality Systems and executing within these systems across Priovant's clinical development programs.

Biotechnology

Responsibilities

Track, upload, and manage documentation required to be in the TMF across studies. This includes working with internal and external collaborators to obtain documentation, respond to queries, and track TMF health

Collaborate with other quality and clinical operations staff on study oversight metric input and review. Additionally, create action plans for metrics that exceed KPIs

Use metrics to identify clinical study sites with higher than desired clinical risk and work to mitigate these risks

Perform clinical site, TMF, and/or vendor site audits, as needed

Support clinical site inspection readiness

Develop and implement procedures for the Priovant Therapeutics Quality Management System (QMS)

Qualification

GCP QualityBiopharmaceutical experienceQuality Management SystemCommunication skillsProblem-solving skillsDecision-making skillsCollaboration skillsAttention to detail

Required

Bachelor's degree in one of the life sciences, or equivalent knowledge and experience

6-12 years of experience in biopharmaceutical industry or related field with experience in GCP Quality, experience in additional GXP disciplines a plus

Organized and thorough, with attention to details

Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results

Demonstrated communication, problem-solving, and decision-making skills

Natural collaborator who enjoys working on a cross-functional team

Company

Priovant Therapeutics

Priovant Therapeutics is a clinical-stage biotechnology company focused on delivering novel therapies.

New York, New York, USA

51-200 employees

https://priovanttx.com/

Funding

Current Stage

Growth Stage

Leadership Team

Benjamin Zimmer

Chief Executive Officer

Courtney Cupples

Chief Commercial Officer (CCO)

Recent News

Spherix Global Insights

Priovant’s Brepocitinib Poised to Address Steroid-Sparing Gap in Dermatomyositis as Rheumatologists Anticipate 2026 Launch

2025-10-10

Seattle TechFlash

Pfizer-backed biotech readies expansion after trial success

2025-09-25

BioWorld Financial Watch

Roivant, Priovant plan NDA on positive dermatomyositis data

2025-09-20

Company data provided by crunchbase