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Sr. Director, Quality Assurance

15+ years
$230,000 - $280,000 USD
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job TitleSr. Director, Quality Assurance
LocationSan Francisco, CA/Hybrid
Salary$230,000 - $280,000 USD
CompanyML Bio Solutions & BridgeBio Pharma

About ML Bio Solutions & BridgeBio Pharma

ML Bio Solutions, a BridgeBio company, is dedicated to developing innovative treatments for Limb Girdle Muscular Dystrophy (LGMD2I/LGMDR9), specifically with their drug BBP-418, which may become the first oral treatment for this condition. BridgeBio Pharma focuses on creating transformative medicines for genetic diseases and cancers. With a robust pipeline across various therapeutic areas, BridgeBio bridges cutting-edge scientific research with drug development.

Responsibilities:

  • Audit Program Management: Oversee internal and external GCP audits, and participate in vendor and investigator site audits.
  • Regulatory Inspections: Manage regulatory inspections and develop/tracking regulatory commitments.
  • Risk Communication: Communicate significant quality or patient safety risks to Executive Management.
  • Cross-functional Collaboration: Partner with internal teams to resolve compliance issues and continuously improve business processes.
  • Regulatory Updates: Keep current on global GxP regulations and make recommendations for policy updates.

Required Qualifications:

  • Bachelor’s degree with 15+ years of clinical Quality experience in the biopharmaceutical industry.
  • Expertise in global GxP regulations and experience in regulatory audits and inspections.
  • Strong verbal and written communication skills, and the ability to interact with cross-functional teams.
  • Willingness to travel 15-20%.

What We Offer:

  • Patient Days, where you hear directly from patients impacted by the conditions we aim to treat.
  • A culture based on patient-first values, scientific excellence, and rapid execution.
  • Flexible PTOmarket-competitive compensation, and career advancement opportunities.
  • collaborative, fast-paced environment with access to learning and development resources.
  • Potential to work on multiple therapeutic areas over time.

BridgeBio's decentralized model empowers teams to focus on advancing science and helping patients, with rapid career advancement for strong performers and a commitment to Diversity, Equity & Inclusion.

For more details, visit ML Bio Solutions and BridgeBio Pharma.