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Associate Director/Director, Quality Assurance Remote - United States

Company: BridgeBio Pharma
Location: Palo Alto
Posted on: June 5, 2024

Job Description:

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), 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 evaluatedinaPhase 3clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.Our focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.TheAssociate Director/Director, Quality Assuranceis responsible for executing and managing the GoodClinical Practice (GCP) Quality and Compliance program at Calcilytix Therapeutics and assigned BridgeBioaffiliates. It requires strong judgment skills and business acumen to advise internal and external criticalstakeholders on interpretation and compliance with international regulations/guidelines, corporatepolicies, and standard operating procedures (SOPs). This individual will be an active participant and critical point of contact in managing regulatory inspections.Responsibilities

  • Support internal and external audit program.
    • Development and management of audit processes/procedures.
    • Lead and/or participate in vendor and clinical site audits.
    • Review and/or approval of audit reports and CAPA responses.
    • Manage and assist with regulatory inspections globally and oversee the development and tracking of regulatory commitments.
    • Communicate critical information regarding significant quality or patient safety risks to Executive Management and key stakeholders.
    • Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation.
    • Assist the organization with developing and continuously improving processes and systems.
    • Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed.No matter your role at BridgeBio, successful team members are:
      • Patient Champions, who put patients first and uphold strict ethical standards
      • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
      • Truth Seekers, who are detailed, rational, and humble problem solvers
      • Individuals Who Inspire Excellence in themselves and those around them
      • High-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills Requirements
        • Minimum Education and Relevant Experience requirement: Bachelor's degree with 12+ years of relevant Quality experience within a biopharmaceutical company or contract research organization; direct industry experience instead of education will be considered.
        • Current knowledge of global GxP regulations
        • Ability to engage in cross-functional interactions with internal and external staff
        • Excellent verbal and written communication skills, with a strong customer focus
        • Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways
        • Develops technical and/or business solutions to complex problems
        • Identifies and applies advanced practices, technical principles, theories and/or concepts and contributes to the development of new principles and concepts
        • Has a comprehensive understanding of current approaches in the industry and the ability to incorporate them into Calcilytix's programs
        • Applies strong analytical and business communication skills
        • Travel required (domestic and international): Approximately 15%What We Offer
          • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
          • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
          • An unyielding commitment to always putting patients first. Learn more about how we do thishere
          • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
          • A place where you own the vision - both for your program and your own career path
          • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
          • Access to learning and development resources to help you get in the best professional shape of your life
          • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
          • Flexible PTO
          • Rapid career advancement for strong performers
          • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
          • Commitment to Diversity, Equity & Inclusion At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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Keywords: BridgeBio Pharma, Palo Alto , Associate Director/Director, Quality Assurance Remote - United States, Executive , Palo Alto, California

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