BridgeBio Pharma

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đź“Ť San Francisco, CA

🧭 Full-Time

đź’¸ 90000.0 - 120000.0 USD per year

🔍 Biotechnology/pharmaceutical

  • Bachelor’s degree in a scientific discipline or equivalent experience.
  • Minimum of 3-4 years of biotech/pharmaceutical industry or CRO experience.
  • Knowledge of the DIA TMF Reference Model and GCP requirements.
  • Experience managing TMF documents and conducting quality control activities.
  • Understanding of data privacy principles such as HIPAA and GDPR.
  • Support implementation and management of record management processes related to the eTMF and ensure compliance with policies.
  • Serve as a subject matter representative and guide team members on documentation best practices.
  • Prepare and manage TMF Plans and Content Lists, ensuring study team and vendor compliance.
  • Perform eTMF quality reviews, identify deficiencies, and track resolution.
  • Maintain eTMF quality metrics and facilitate TMF QC activities.

Microsoft Excel

Posted about 2 months ago
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đź“Ť United States

🧭 Full-Time

đź’¸ 225000.0 - 260000.0 USD per year

🔍 Biopharmaceutical

  • Demonstrated expertise in guiding the development of the Quality Management System.
  • Ability to build relationships and collaborate effectively.
  • Strong negotiation skills and flexibility in a solution-based approach.
  • Capable of managing multiple projects and time demands efficiently.
  • Bachelor's degree in a scientific discipline or equivalent experience.
  • Minimum of 8 years of experience in a GCP practice area, preferably Clinical Quality Assurance.
  • Expertise with applicable GCP guidelines.
  • Experience with Veeva platform is highly preferred.
  • Lead the development and maintenance of Clinical aspects of BBGT’s Quality Management System.
  • Support inspection readiness and audits by external sources.
  • Manage direct reports and consultants to meet clinical quality objectives.
  • Coordinate documentation of quality events and corrective actions.
  • Provide Clinical Quality Assurance leadership to clinical study teams.
  • Author and maintain QA Standard Operating Procedures (SOPs).
  • Support training oversight in collaboration with functional leads.
  • Lead process improvement projects as necessary.
  • Conduct internal and external service provider audits.

LeadershipGCPQuality AssuranceProcess improvement

Posted about 2 months ago
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đź“Ť United States

đź’¸ 245000.0 - 285000.0 USD per year

🔍 Biopharmaceutical

  • Bachelor’s Degree in Pharmacy, Biology, Chemistry or Microbiology, or related field.
  • Preferred Master’s degree and regulatory affairs certification.
  • 10+ years of pharmaceutical or regulatory experience, including 8 years in a pharmaceutical environment and 3 years in a leadership role.
  • Strong knowledge of US and EU product labeling requirements and regulations.
  • Excellent project management and communication skills.
  • Provide regulatory expertise and guidance for global regulatory labeling strategy.
  • Collaborate with regulatory teams on global labeling activities.
  • Lead partnerships with internal stakeholders and the Label Working Group.
  • Ensure compliant management of labeling documents and assess global regulatory environments.
  • Develop best-in-class labeling processes and oversee CCDS and labeling deliverables.

LeadershipProject ManagementCross-functional Team LeadershipGoCommunication SkillsAnalytical SkillsCollaborationProblem SolvingNegotiationAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communicationDocumentation

Posted 4 months ago
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