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Associate Director / Director, Quality Operations and Inspection Management

Associate Director / Director, Quality Operations and Inspection Management

BridgeBioSan Francisco, CA, United States
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Overview

Associate Director / Director, Quality Operations and Inspection Management

Join to apply for the Associate Director / Director, Quality Operations and Inspection Management role at BridgeBio . This role supports GCP and GVP inspections and helps develop and continuously improve processes and systems related to Quality Operations and Inspection Management.

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

Base pay range : $170,000.00 / yr - $235,000.00 / yr

Salary information is provided for candidates in California; final offer determined by experience and other factors.

Seniority level : Director. Employment type : Full-time. Job function : Quality Assurance.

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 improving processes and systems. This role requires strong organization skills to manage inspection readiness and SOP activities and timelines. Strong knowledge of GCP and GVP-related regulations is preferred.

Responsibilities

  • Support GCP and GVP inspections
  • Partner with internal and external stakeholders to support inspection readiness activities for BridgeBio affiliates
  • Assist cross-functional teams during preparation, execution, and closure of GCP and GVP health authority inspections; coordinate with vendors and investigational sites for external inspections as appropriate
  • Back room lead / co-lead for managing regulatory inspection activities, tracking requests and inquiries, and coordinating responses
  • Support / lead inspection readiness meetings and trainings; coordinate mock inspections
  • Manage inspection commitments and effectiveness checks
  • Maintain Inspection database
  • Quality Operations
  • Support R&D-related SOP review and approval within QA and across functionals
  • Support development and tracking of QMS and training-related metrics
  • Lead all GCP / GVP QMS activities
  • System updates and improvements; oversight of deviations, CAPAs, and continuous improvement
  • Oversee periodic GCP and GVP training planning and guidance
  • Stay current with regulatory changes and recommend policy updates as needed

What You Are

  • Bachelor’s degree with 10+ years of relevant clinical Quality experience in 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 with a strong customer focus
  • Approximately 10-15% travel

    • Benefits & Rewards

  • Financial benefits : market leading compensation; 401K with employer match; employee stock purchase program; pre-tax commuter benefits; referral program
  • Health & wellbeing : comprehensive health coverage; mental health support; hybrid work model; unlimited flexible paid time off; paid parental leave; flexible spending accounts; life and disability insurance; subsidized meals
  • Skill development & career paths : opportunities for internal mobility; regular feedback and development programs

    • For reference, this description may include additional context about BridgeBio and its affiliates. The final salary offer depends on experience, location, and interview performance. BridgeBio is a multi-state employer; salary ranges may vary by state.

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    Quality Inspection • San Francisco, CA, United States