Sr. Manager, QA Operations - Product Release

📋 Description

• • As a Sr. Manager, QA Operations - Product Release at BridgeBio Pharma, you will be at the forefront of ensuring the quality and compliance of our life-changing medicines by managing critical lot release activities at our Contract Manufacturing Organizations (CMOs).
• • You will serve as the primary QA Operations lead for assigned CMOs, taking ownership of the comprehensive review of manufacturing batch records, Certificates of Analysis (CoAs), and the meticulous issuance of Certificates of Compliance (CoCs).
• • Your role will be pivotal in ensuring that all CMO Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) strictly adhere to current Good Manufacturing Practices (cGMP), safeguarding the integrity and safety of our products.
• • You will act as the technical quality reviewer for all quality events, including deviations, change records, protocols, and Corrective and Preventive Actions (CAPAs) that originate from or pertain to Calcilytix or other BridgeBio affiliates, ensuring thorough investigation and resolution.
• • Representing QA Operations, you will be an integral part of internal and external project teams, actively participating in audits and inspections, and diligently monitoring CMO performance to uphold our high standards.
• • Your responsibilities will extend to the detailed review and management of both master and executed manufacturing batch records from CMOs, encompassing all release activities and associated documentation such as specifications, analytical and microbiological methods, stability studies/protocols, and process and method validation protocols and reports.
• • You will be responsible for authoring and performing quality reviews of SOPs and quality events, including deviations/investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) results, change controls, and supplier notifications, ensuring a robust quality system.
• • A key aspect of your role will be leading the disposition of Drug Substance (DS), Drug Product (DP), and Finished Product (FP), making critical decisions that impact product availability and patient access.
• • You will be the key communicator and escalator of manufacturing deficiencies or non-conformances to management, presenting complex issues during escalation meetings and collaborating with CMOs to ensure timely and effective resolution.
• • Your expertise will be crucial in supporting regulatory filings, contributing to the successful submission and approval of our innovative therapies.
• • You will also play a vital role in supporting audits of CMOs, ensuring they meet BridgeBio's stringent quality requirements and regulatory expectations.
• • This hybrid role offers flexibility, requiring in-office collaboration 2-3 times per week in our San Francisco office, or a U.S.-based remote option with quarterly visits to our San Francisco office, allowing you to balance your work and personal life.
• • BridgeBio's unique "moneyball for biotech" approach fosters an environment of curiosity, experimentation, and rapid innovation, where you can work alongside respected minds in the industry to redefine the future of biopharma.
• • You will be empowered to defy convention, ask "why not?", and contribute to developing life-changing medicines for patients with unmet needs as fast as humanly possible.
• • Embrace the opportunity to work in a dynamic environment that values ethical and thoughtful use of AI to improve clarity, speed, and quality of work, pushing the boundaries of what's possible in drug development.
• • This position offers a significant opportunity to impact patient lives by ensuring the quality and timely release of critical pharmaceutical products, contributing directly to BridgeBio's mission of bringing transformative medicines to those who need them most.
• • You will be instrumental in maintaining the highest standards of quality and compliance throughout the product lifecycle, from manufacturing to final release, ensuring patient safety and product efficacy.
• • Your contributions will be vital in navigating the complex regulatory landscape and ensuring that BridgeBio's products meet all global compliance requirements.
• • This role demands a proactive, detail-oriented individual who can manage multiple priorities and drive results in a fast-paced, innovative environment.
• • You will have the opportunity to grow your career within a rapidly expanding company that is making a significant impact in the rare disease space.
• • Your work will directly contribute to bringing novel therapies to patients, embodying BridgeBio's commitment to scientific excellence and patient-centricity.