Manager, Quality Operations, ROW Distribution

About BridgeBio Pharma, Inc.  BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease.

We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide.  Who We Are  BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland.

Since establishing our European presence in 2021, we’ve been building empowered, high-performing teams across countries — experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth.  At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision-making.

We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world.  What You’ll Do  The Quality Operations Manager for ROW Product Distribution reports directly to the Senior Manager of Quality Assurance at BridgeBio Netherlands.

This role is responsible for ensuring that distributed products consistently meet all applicable regulatory and internal standards throughout the entire distribution lifecycle. Key duties include overseeing quality from product release through customer delivery, evaluating distribution deviations and conducting investigations, and facilitating collaboration with suppliers and internal teams such as Quality Control, Manufacturing, Regulatory Affairs, and Supply Chain.

The position demands exceptional analytical, organizational, and communication abilities.    Responsibilities  Manage batch release activities for distribution and communication of batch release schedules to key stakeholders  Ensure that required licenses at the distributors are available and current  Ensure Distributors are set-up in company’s approved list  Create, review and approve certificate of analysis applicable for specific markets  Ensure the quality and integrity of product during storage, transportation, and distribution  Ensure compliance with packaging requirements  Perform quality review and guide quality events (deviations, change requests, distributor notifications, etc.) as documented by contract distributors  Communicate distribution deficiencies/non-conformances to management and work with internal stakeholders and distributors to ensure timely resolution  Other Quality Assurance related responsibilities  Participate in the GDP/GMP qualification and audit of Distributors   Collaborate with the third-party logistics (3PL) providers to ensure they meet quality expectations   Participate in regulatory inspections at the Distributors as needed  Monitor Distributor performance using statistical analysis to report on key performance indicators (KPIs) and quality metrics to management  Participates as QA person-in-plant, internal, and external meetings  Write and review SOPs and quality assurance procedures  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.    Where You’ll Work    This is a NL-based remote role that may require around 15% of travel to San Francisco, Switzerland and distributors as needed.  Who You Are  Education: Bachelor’s degree or equivalent in operations, science, supply chain, engineering required    Experience / Background:   Prior experience with a commercial product  Prefer experience in oversight of external vendors and customers  Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers  Ability to interact successfully in a diverse environment  Strong analytical and organizational skills  Ability to engage in cross-functional interactions with internal and external staff  Strong planning and time management skills with the ability to prioritize workload  Proficiency in document and presentation office tools (Microsoft Office, Excel, etc.)  Basic understanding of data concepts and enterprise resource planning (ERP) systems  Ready to embrace companies’ core values and diverse corporate culture  Qualifications:  Minimum 6 years of experience (or 3 years with Master’s Degree) in quality assurance, distribution, logistics role in the pharmaceutical industry   Extensive knowledge of regulations, guidelines and standards related to cGMPs (CFR/ICH/EMA), and distribution (GDP) of medicinal products  Rewarding Those Who Make the Mission Possible  We have high expectations for our team members.

We make sure those working hard for patients are rewarded and cared for in return.   Market leading compensation   Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community  We provide career development through regular feedback, continuous education and professional development programs  We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.   

BridgeBio Pharma (NASDAQ: BBIO) is a biopharmaceutical company dedicated to advancing a diverse pipeline of medicines that target genetic diseases. Founded in 2015, BridgeBio is committed to developing innovative therapies that address unmet medical needs in various rare and genetic diseases. With a focus on precision medicine and a patient-centered approach, BridgeBio is at the forefront of revolutionizing treatment options for individuals affected by genetic disorders.