Manager, Quality Operations, ROW Distribution at Aspa Therapeutics

Description

<h3></h3> <h3>About&nbsp;BridgeBio&nbsp;Pharma, Inc.&nbsp;</h3> BridgeBio&nbsp;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&nbsp;therapies&nbsp;and&nbsp;continue to advance promising science from academia into meaningful treatments for patients worldwide.&nbsp; <h3>Who We Are&nbsp;</h3> 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.&nbsp; At&nbsp;BridgeBio,&nbsp;you’ll&nbsp;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.&nbsp; <h3>What&nbsp;You’ll&nbsp;Do&nbsp;</h3> The Quality Operations Manager for ROW Product Distribution reports directly to the Senior Manager of Quality Assurance at&nbsp;BridgeBio&nbsp;Netherlands. This role&nbsp;is responsible for&nbsp;ensuring that&nbsp;distributed&nbsp;products consistently meet all applicable regulatory and internal standards throughout the entire&nbsp;distribution&nbsp;lifecycle. Key duties include overseeing quality from product release through customer delivery, evaluating distribution deviations and conducting investigations, and&nbsp;facilitating&nbsp;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.&nbsp;&nbsp;&nbsp; <h3>Responsibilities&nbsp;</h3> <ul> <li>Manage batch release activities for distribution and communication of batch release schedules to key stakeholders&nbsp;</li> <li>Ensure that&nbsp;required&nbsp;licenses at the distributors are available and current&nbsp;</li> <li>Ensure Distributors are set-up in company’s approved list&nbsp;</li> <li>Create,&nbsp;review&nbsp;and approve certificate of analysis applicable for specific markets&nbsp;</li> <li>Ensure the quality and integrity of product during storage, transportation, and distribution&nbsp;</li> <li>Ensure compliance with packaging requirements&nbsp;</li> <li>Perform quality review and guide quality events (deviations, change requests, distributor notifications, etc.) as documented by contract distributors&nbsp;</li> <li>Communicate distribution deficiencies/non-conformances to management and work with internal stakeholders and distributors to ensure&nbsp;timely&nbsp;resolution&nbsp;</li> </ul> Other Quality Assurance related responsibilities&nbsp; <ul> <li>Participate in the GDP/GMP qualification and audit of Distributors&nbsp;&nbsp;</li> <li>Collaborate with the third-party&nbsp;logistics&nbsp;(3PL) providers to ensure they meet quality expectations&nbsp;&nbsp;</li> <li>Participate in regulatory inspections at the Distributors as needed&nbsp;</li> <li>Monitor Distributor performance using statistical analysis to report on key performance indicators (KPIs) and quality metrics to management&nbsp;</li> <li>Participates as QA person-in-plant, internal, and external meetings&nbsp;</li> <li>Write and review SOPs and quality assurance procedures&nbsp;</li> </ul> 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&nbsp;required of&nbsp;job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or&nbsp;required, as training and experience allow.&nbsp;&nbsp;&nbsp; <h3>Where&nbsp;You’ll&nbsp;Work&nbsp;&nbsp;&nbsp;</h3> This&nbsp;is&nbsp;a&nbsp;NL-based remote role that&nbsp;may&nbsp;require&nbsp;around&nbsp;15%&nbsp;of&nbsp;travel&nbsp;to San Francisco, Switzerland and distributors as needed.&nbsp; <h3>Who You Are&nbsp;</h3> Education: Bachelor’s degree or equivalent in operations, science, supply chain, engineering&nbsp;required&nbsp;&nbsp;&nbsp; Experience / Background:&nbsp;&nbsp; <ul> <li>Prior experience with a commercial product&nbsp;</li> <li>Prefer experience in oversight of external vendors and customers&nbsp;</li> <li>Comfortable&nbsp;working in a virtual bio-pharmaceutical organization with multiple global third-party providers&nbsp;</li> <li>Ability to interact successfully in a diverse environment&nbsp;</li> <li>Strong analytical and organizational skills&nbsp;</li> <li>Ability to engage in cross-functional interactions with internal and external staff&nbsp;</li> <li>Strong planning and time management skills with the ability to prioritize workload&nbsp;</li> <li>Proficiency&nbsp;in document and&nbsp;presentation&nbsp;office tools (Microsoft Office, Excel, etc.)&nbsp;</li> <li>Basic understanding of data concepts and enterprise resource planning (ERP) systems&nbsp;</li> <li>Ready to embrace companies’ core values and diverse corporate culture&nbsp;</li> </ul> Qualifications:&nbsp; <ul> <li>Minimum 6 years of experience (or 3 years with&nbsp;Master’s Degree) in quality assurance, distribution,&nbsp;logistics&nbsp;role in the pharmaceutical industry&nbsp;&nbsp;</li> <li>Extensive knowledge of regulations, guidelines and standards related to&nbsp;cGMPs&nbsp;(CFR/ICH/EMA), and distribution (GDP) of medicinal products&nbsp;</li> </ul> <h3>Rewarding Those Who Make the Mission Possible&nbsp;</h3> We have&nbsp;high expectations&nbsp;for our team members. We make sure those working hard for patients are rewarded and cared for in return.  &nbsp; <ul> <li>Market leading compensation &nbsp;</li> <li>Hybrid work model -&nbsp;we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community&nbsp;</li> <li>We provide career&nbsp;development&nbsp;through regular feedback, continuous&nbsp;education&nbsp;and professional development programs&nbsp;</li> <li>We celebrate&nbsp;strong performance&nbsp;with financial rewards, peer-to-peer recognition, and growth opportunities.&nbsp;</li> </ul> &nbsp;

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Manager, Quality Operations, ROW Distribution

Description

Aspa Therapeutics