• Job Description

  Req#: 32416892993

  All Jobs > Sr/ Director, Quality Assurance

  GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

  Position Overview: The Sr/Director of Quality Assurance is responsible for developing, maintaining, and overseeing Good Clinical Practice (GCP) activities related to clinical trials. The primary responsibilities include ensuring quality and compliance of clinical trials with company policies, procedures, and applicable regulatory requirements (US FDA, ICH, and country-specific standards). The role involves working closely with clinical study teams to foster a culture of quality, regulatory compliance, and inspection readiness.

  Responsibilities:

  1. Lead the development, management, and continuous improvement of Clinical aspects of GBIO's Quality Management System procedures.
  2. Oversee inspection readiness activities and support audits and inspections by external agencies (e.g., health authorities).
  3. Manage direct reports, consultants, and contractors to achieve Clinical Quality Assurance objectives.
  4. Coordinate with clinical study teams on documentation of quality events, CAPA plans, and related activities.
  5. Provide leadership and SME support for Clinical Quality Assurance to clinical study teams.
  6. Author and maintain QA SOPs and support training oversight in collaboration with functional leads.
  7. Lead process improvement projects as needed.
  8. Review clinical protocols, amendments, Clinical Study Reports, and related documents for quality assurance.
  9. Plan and conduct internal and external audits, review audit reports, and oversee CAPA actions.
  10. Collaborate with GMP QA and CMC teams on enterprise-wide QMS topics.
  11. Perform other duties as assigned.

  Qualifications:

  • Proven expertise in developing and guiding a Quality Management System.
  • Strong interpersonal skills to build collaborative relationships across departments and with vendors.
  • Excellent negotiation skills, flexibility, and problem-solving abilities.
  • Ability to manage multiple projects and adapt to changing priorities.
  • Thorough knowledge of regulations such as 21CFR Parts 11, 210, 211, 312, 314; ICH Q1–Q10; E6.
  • Bachelor's degree in a scientific discipline required; Master's preferred.
  • At least 8 years of experience in GCP or related Clinical Quality Assurance roles.
  • Expertise with GCP guidelines and experience with Veeva platform is highly preferred.

  What We Offer:

  • Engagement with patient stories to inform our efforts.
  • A culture driven by core values: put patients first, think independently, be radically transparent, value time, and prioritize science.
  • Dedicated commitment to patient-centricity.
  • A decentralized structure promoting science and patient focus.
  • Ownership of your program and career development.
  • Collaborative, fast-paced, data-driven environment.
  • Access to professional development resources.
  • Competitive compensation & benefits including base salary, bonuses, equity, and health plans.
  • Flexible PTO and opportunities for rapid career growth.
  • Potential to work across multiple programs and therapeutic areas.
  • Commitment to diversity, equity, and inclusion.

  Note: The salary range applies to candidates in California and may vary based on experience, education, location, and performance. GondolaBio is a multi-state employer.

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• About the company

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