About BridgeBio

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 20+ 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 aim 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.

To learn more about our story and company culture, visit us at https://bridgebio.com

Who You Are

The Quality Assurance Manager will report directly to the Vice President of Quality, CMC. This position will manage quality assurance lot release activities for the disposition of drug substance (DS), drug product (DP), and finished drug products manufactured by BridgeBioContract Manufacturing Organizations (CMOs), Contract Packaging Organizations (CPOs), and/or Contract Testing Laboratories (CTLs), referred to here as Suppliers. This position will serve as a quality liaison with assigned Suppliers, including new product introductions, management of the review and approval of manufacturing batch records, certificates of analysis, and the issuance of compliance certificates. The position will ensure that all batch records comply with cGMPs. This position will serve as the primary technical quality reviewer and approver for deviations, change records, and CAPAs generated from or pertaining to assigned Suppliers. This position will require solid cross-functional collaboration with trusted Suppliers and internal stakeholders such as quality control, manufacturing, regulatory affairs, and supply chain.  

Responsibilities

• Provide oversight and quality support of third-party manufacturing sites, including drug substance, drug product, analytical, packaging, and labeling sites, primarily located in the EU and UK
• Perform quality review and guide quality events (deviations, change requests, supplier notifications, etc.) as documented by Suppliers and manufacturing operations departments
• Develop quality assurance capabilities to support new product introductions
• Represent QA on project teams for assigned Suppliers
• Review master and manufacturing batch records from Suppliers, including related documents such as specifications, analytical and microbiological methods, stability study protocols, and label proofs
• Manage lot release activities and communication of lot release schedules to key stakeholders
• Communicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolution
• Participate in the GMP vendor qualification and audit programs and monitor Supplier performance
• Review process and method validation protocols and reports
• Review analytical test results to ensure compliance with approved specifications
• Assist in updating CMC sections of regulatory and quality documents 
• Participate in hosting regulatory inspections
• Participate in internal and external project team meetings
• Write and review SOPs and quality assurance procedures
• Position could have a responsibility to manage subordinates in the future
• Other duties as assigned

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.  

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 speed

Education, Experience & Skills Requirements

• Bachelor’s degree or equivalent in operations, science, mathematics, or engineering required  
• Extensive knowledge of US and European drug substance and drug product GMP requirements and associated guidelines
• Must have previous experience with managing international pharmaceutical CMOs/CPOs/CTLs 
• Experience in the identification and resolution of GMP quality and compliance issues
• Strong understanding of supply chain concepts, supplier management, and inventory management
• Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
• Vital planning and time management skills with the ability to prioritize workload
• Excellent analytical and problem-solving skills, with keen attention to detail
• Proficiency in document and presentation office tools (Microsoft Office, Google Docs, etc.)
• Basic understanding of data concepts and enterprise resource planning (ERP) systems
• Previous experience managing subordinates 
• Ready to embrace companies core values and diverse corporate culture
• Minimum ten years of experience (or eight years with a Master’s Degree) in a quality assurance role in the pharmaceutical industry required
• Travel estimate:  15% of the time
• Eligible to work in The Netherlands

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
• 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
• Commitment to Diversity, Equity & Inclusion