Associate Director / Director, Quality Operations and Inspection Management

Associate Director / Director, Quality Operations And Inspection Management

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Calcilytix Therapeutics, an affiliate within BridgeBio Pharma, is developing encaleret, a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA. Results from the Phase 2b clinical study of encaleret in patients in ADH1 were published in the New England Journal of Medicine.

What You'll Do

The Associate Director / Director, Quality Operations and Inspection Management is responsible for supporting GCP and GVP inspections and assisting the organization with developing and continuously improve processes and systems. This position requires strong organization skills to help manage inspection readiness and standard operating procedures (SOPs) activities and timelines. Strong knowledge of GCP and GVP related regulations preferred.

Responsibilities

• Support GCP and GVP Inspections :

Partner with internal and external key stakeholders to support assigned BridgeBio affiliates in inspection-readiness activities

Serving as the back room lead / co-lead responsible for managing, and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide

Support R&D-related SOP review and approval process within QA and across functional areas

System updates and improvements

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.

Who You Are

Rewarding Those Who Make The Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Financial Benefits :

Health & Wellbeing :

Skill Development & Career Paths :

Salary : $170,000 - $235,000 USD