Associate Director/Director, Quality Operations and Inspection Management

Mavericks Wanted

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
  • Support the cross functional teams during the preparation, execution, and closure of GCP and GVP health authority inspections and partner with vendors and investigational sites to support external Inspections as appropriate. Examples include:
    • 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/lead inspection readiness meetings and timelines; assist in coordination of mock inspections; and inspection readiness trainings
    • Manage inspection commitments and effectiveness checks
    • Maintain Inspection database
• Quality Operations:
  • Support R&D-related SOP review and approval process within QA and across functional areas
  • Support development and tracking of QMS and training related metrics
  • Lead all GCP/GVP Veeva QMS activities
    • System updates and improvements
    • Oversight of Internal and External Deviations, CAPAs, and Continuous Improvements
  • Oversee the planning of periodic GCP and GVP training and provide guidance on GCP and GVP training activities
  • Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed

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

• Bachelor’s degree with 10+ years of relevant clinical Quality experience within a biopharmaceutical company
• Current knowledge of global GxP regulations
• Ability to engage in cross-functional interactions with internal and external staff
• Excellent Organizational skills
• Excellent verbal and written communications skills, with a strong customer focus
• Approximately 10-15% travel

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:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program