Sr. Director, Quality Assurance CMC
April 26
🔄 Hybrid – San Francisco
Description
• Review and approve specifications affecting product quality and oversee the development of batch records, validation protocols • Oversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of commercial and other late-phase therapeutic areas • Disposition of clinical and commercial batches • Interacts with manufacturing, clinical, operations, or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identified • Review and approve change controls, deviations, investigations, OOX, CAPA, and Product Quality Complaints • Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities • Support vendor qualification program, review written reports, follow up to resolve findings, and monitor vendor performance • Review clinical and commercial Quality Agreements to meet quality operation and compliance requirements • Prompt communication to management of critical and/or compliance issues • Participate in Quality Management meetings such as MRB, CCRB, QMR, etc. • Review process and method validation protocols and reports • Assist in updating CMC sections of regulatory and quality documents • Participate in hosting regulatory inspections • Participate in the site inspection readiness program • Support internal audit program that is focused on prevention versus correction • Participate in internal and external project team meetings • Support QMS in support of late-stage and commercial activities • Participates in continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness, and enhanced efficiencies of processes and procedures as they pertain to quality • Position could have a responsibility to manage subordinates in the future • Other duties as assigned
Requirements
• Documented training and/or certification in relevant quality fields (e.g. ASQ) a plus • At least 15 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry; 5 years prior management or leadership role preferred • Previous experience with FDA inspections and interaction with FDA • Experience in small molecule drug substance and solid oral dose production and development, packaging/labeling/serialization, third-party logistics, and supporting continuous clinical trial medicine supplies. Commercial manufacturing experience is a plus • Demonstrated track record in effectively managing and implementing GMP-compliant quality systems • Expert knowledge of GMP regulations • Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals • Excellent verbal and written communication skills • Ability to think critically and take a collaborative approach to problem-solving • Ability to work effectively in a regulated and fast-paced environment • Demonstrates a high level of professional integrity and trustworthiness with strong work ethics • Position requires 10-20% travel. Must have the ability to travel internationally
Benefits
• 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 this at https://bridgebio.com/about • 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 • Partnerships with leading institutions • Commitment to Diversity, Equity & Inclusion
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