Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Medical Writing-Publications will provide strategic direction within the department and lead the successful development and tactical execution of publication plans across multiple programs in alignment with integrated evidence generation plans and lifecycle strategies and in compliance with SOPs, publication guidelines, and company goals. In addition, the Senior Director will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, including distribution of work to medical writers or agencies as needed. They will serve as the primary contact for publication activities in collaboration with a cross‐functional group, including Clinical Development, Medical Affairs, Biometrics, Pharm/Tox, Research, and other relevant functions.  

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Lead key strategic initiatives within the department including publication strategy, planning, and execution of Ultragenyx products and pipeline publication plans, ensuring alignment with department and company goals. 
2. Provide leadership within the department by proposing and overseeing new initiatives and capabilities, such as establishing best practices for pubs strategy development and pull-through. 
3. Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses and provide publication support and ensure compliant development of company-sponsored publications. 
4. Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions).  
5. Liaise with relevant corporate functions and partner(s), as applicable, to ensure appropriate communication of publications‐related activities including manuscripts and congress abstracts/posters/presentations. 
6. Uses advanced communication and persuasion strategies to negotiate on behalf of their department or function on strategic matters. 
7. Contributes to strategic planning for the broader function and support high‐quality execution of Corporate‐wide initiatives. 
8. Acts as a trusted advisor and recognized technical expert. 
9. Manage and/or mentor junior medical writers and contractors. 
10. Support publication budget planning and management. 

Requirements:

1. BS, MS, or doctorate in a scientific or medical field. 
2. Solid experience (BS with >15 years or advanced degree with >10 years) in publication management and medical writing in the biotechnology/pharmaceutical industry preferred. 
3. Proven success with leading and managing medical writing agencies as well as track record for consistently meeting or exceeding quantitative targets. 
4. Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of applicable publications-related guidelines (i.e., ICMJE, GPP) and best practices, as well as legal, regulatory, compliance, and clinical/medical affairs. 
5. Experience writing and preparing manuscripts for publication in peer‐reviewed journals as well as abstracts, posters, and slide decks for presentation at scientific congresses. 
6. Successful and superior influencing skills across all levels of the organization and external collaborators. 
7. Exceptional oral and written communication skills. 
8. Experience in successfully engaging with cross‐functional product teams. 
9. Strong organizational abilities and experience in a multitasking environment. 
10. Motivated, self‐directed, and able to work autonomously and in team settings to meet aggressive organizational goals. 
11. Rare disease experience and a strong understanding of neurodevelopmental disorders are a plus. 

#LI-CS1 #LI-Hybrid, or #LI-Remote

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced Senior Director, Supply Chain Quality to provide global quality leadership and oversight across packaging, labeling, global logistics, distribution, and external supply chain partners supporting both clinical and commercial products. 

This role is accountable for establishing and maintaining a robust global Good Distribution Practice (GDP) quality framework that ensures compliant, reliable, and patient centric delivery of biologics, small molecule, antisense oligonucleotide (ASO), and gene therapy products. The successful candidate will bring deep hands-on experience with global GDP requirements, temperature controlled supply chains, and complex international distribution networks, and will serve as the quality authority for supply chain operations across internal teams and external partners. 

As a senior quality leader, this role will shape strategy, build organizational capability, and drive continuous improvement across the supply chain while ensuring inspection readiness and regulatory compliance globally. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. 

Responsibilities:

• Provide global quality leadership and oversight for supply chain, packaging, labeling, warehousing, transportation, and distribution activities supporting clinical and commercial products.  

• Establish, implement, and maintain a robust global Good Distribution Practice (GDP) quality strategy, ensuring compliance with FDA, EMA, MHRA, WHO, PIC/S, and other applicable global regulations.  

• Serve as the Quality subject matter expert for complex global distribution models, including cold chain, ultra-cold chain, and controlled ambient logistics.  

• Provide QA oversight of packaging and labeling operations, including artwork approval, labeling controls, serialization/traceability, tamper-evident systems, and country-specific labeling requirements.  

• Lead qualification, oversight, and performance monitoring of external supply chain partners, including CMOs, 3PLs, freight forwarders, depots, and packaging vendors.  

• Ensure quality agreements clearly define GDP responsibilities, escalation pathways, compliance expectations, and performance metrics for all external partners.  

• Integrate GDP processes into the Quality Management System (QMS), including deviations, CAPAs, change control, complaints, risk management, and management review.  

• Lead and oversee investigations related to temperature excursions, shipment deviations, labeling errors, and distribution complaints, ensuring effective root cause analysis and sustainable corrective and preventive actions.  

• Serve as the quality representative for regulatory inspections and audits related to supply chain, distribution, packaging, and labeling, and support Health Authority and Qualified Person (QP) interactions.  

• Partner cross-functionally with Supply Chain, Technical Operations, Regulatory Affairs, Clinical Operations, and Commercial teams to support distribution network design, launch readiness, lifecycle management, and continuous improvement, while fostering a strong culture of quality and compliance. 

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.  

• 15+ years of Quality Assurance experience in the biopharmaceutical industry, with substantial leadership responsibility in supply chain quality and GDP.  

• Demonstrated hands-on expertise in global GDP requirements, including EU GDP, U.S. distribution expectations, and international regulatory standards.  

• Proven experience supporting clinical and commercial distribution of temperature-sensitive products across global markets.  

• Experience working with biologics, small molecules, and advanced therapies (gene therapy and/or cell therapy experience strongly preferred).  

• Strong track record of leading and supporting regulatory inspections and audits (e.g., FDA, EMA, MHRA) related to supply chain and distribution.  

• Deep understanding of cGMP, GDP, and global regulatory expectations across U.S. and ex-U.S. regions.  

• Demonstrated ability to effectively manage and influence external partners, including CMOs, 3PLs, and logistics service providers.  

• Proven senior leadership presence with the ability to influence without direct authority in a matrixed, fast-paced environment.  
• Willingness and ability to travel approximately 15–20%, including domestic and international travel, as required. 

Physical Demand Requirements: 

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Working in temperature-controlled environments (cold rooms)  

#LI-CS1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager, CMC QA will be responsible for the Product Complaints, Annual Product Quality Review and CMC Change Control Review Board programs and will maintain strategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyx’s CMC quality approach for the company. This role will direct and oversee operations in accordance with GxP regulations and Ultragenyx standards. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC 
2. Lead UGX Change Control Review Board program and provide coaching to Change Owners on the Change Control process as needed 
3. Support the release of production lots in accordance with Ultragenyx procedures 
4. Execution of Quality Systems in an Owner/SME or QA role, for Deviations, Change Controls and Product Quality Complaints 
5. Lead and actively participate in Continuous Improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners 
6. Design, develop, and review CMC QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department 
7. Support the Product Complaints function in investigating reported product quality events, as needed 
8. Represent Ultragenyx to Health Authorities during inspections 
9. Ensure activities and deliverables comply with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices. 
10. Communicate and promote a culture of quality and operational excellence  
11. Other duties as assigned 

Requirements:

1. A Bachelor’s degree or equivalent work experience in QA Manufacturing Operations or related discipline.  
2. 8+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality. 
3. Experience with management of Change Control process and Review Board. 
4. Experience with Product Disposition.  
5. Demonstrate quality mindset and influences across the entire organization. 
6. Strong understanding unique quality and manufacturing expectations from other regulatory authorities such as EMA, ANVISA, MHRA, etc. 
7. Expert knowledge of GMPs. 
8. Flexibility and the ability to manage change. 
9. Strong interpersonal skills and the ability to work well as part of a team. 
10. Demonstrated ability for analytical and systematic thinking. 
11. Experience with Product Complaint handling, investigations, and reporting a plus. 
12. Fosters an environment of accountability, diversity and speaking up. 
13. Demonstrated high personal and professional ethical standards. 
14. Travel up to 10% of total work hours.  

#LI-CT1 #LI-Hybrid

Position Summary:

We are seeking a seasoned Senior Network Systems Architect to lead the evolution of our global hybrid network and systems infrastructure. This role requires a strong foundation in Cisco Meraki, Azure Cloud networking, and Cisco ASA. The ideal candidate will bring hands-on expertise in designing, scaling, and supporting both on-premises and cloud environments, while contributing to a secure, reliable, and high-performing enterprise network. 

Familiarity with automation tools such as Python, Terraform, and Ansible is preferred, but not mandatory for success. Experience working with Managed Service Providers (MSPs) and global telecom carriers to negotiate contracts and provision circuits is essential. This position combines architecture with day-to-day operational support, requiring a balance of strategic planning and practical execution. 

ultracurious – Apply your biggest ideas in courageous ways

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Manage day to day operations, Architect, deploy, and manage hybrid infrastructure environments using Cisco Meraki, Azure networking services, and Cisco ASA firewalls 

• Design and templatize scalable Meraki configurations and maintain consistent deployment practices across locations 

• Create and maintain Hub-and-Spoke network architectures across Azure regions, ensuring resiliency, segmentation, and traffic control 

• Provide a solid understanding of routing protocols, Azure routing, UDRs, NAT gateways, VPN/ExpressRoute gateways, and NVA-based architectures with multi-region failover support 

• Develop and maintain architectural documentation including high-level designs, topology diagrams, and operational procedures 

• Support operational excellence by serving as an escalation point for L1/L2/L3 network and systems issues and ensuring timely resolution 

• Perform deep packet inspection and network troubleshooting using tools like Wireshark and NetFlow 

• Participate in the planning, procurement, and provisioning of global circuits, including direct engagement and negotiation with carriers and service providers 

• Collaborate with MSPs and internal teams to manage operations, incidents, capacity planning, and global deployments 

• Familiar with automation tools such as Python, Terraform, and Ansible to streamline network and systems workflows 

• Utilize tools like ThousandEyes, Azure Monitor, and log analytics to ensure observability and proactive incident response 

• Ensure strong cross-functional collaboration with IT security, infrastructure, and compliance teams 

• Support growth and scaling initiatives by addressing evolving infrastructure needs, integrating new locations, and expanding global connectivity 

• Contribute to the recruitment, mentorship, and development of junior and mid-level engineers 

Requirements:

• 7+ years of experience in network and systems architecture, with a blend of cloud and on-premises responsibilities 

• Strong hands-on experience with Cisco Meraki, Cisco ASA, and Azure Firewall, as well as Azure network design and deployment 

• Solid understanding of core networking concepts such as BGP, IPsec, and high-availability configurations 

• Demonstrated experience managing or collaborating with MSPs and supporting global operations 

• Experience negotiating with and provisioning circuits through global telecom carriers 

• Strong analytical and troubleshooting skills, especially in production environments 

• Comfortable handling operational demands, including incident response, change control, capacity planning, and documentation 

• Excellent communication and interpersonal skills, with experience engaging both technical teams and senior stakeholders 

• Ability to manage shifting priorities and infrastructure needs as the company grows and scales globally 

Preferred Qualifications: 

• Bachelor’s degree in computer science, Engineering, or a related field, or equivalent work experience 

• Prior experience working in pharmaceutical or regulated industries 

• Working knowledge of Windows Server, Active Directory, DNS, DHCP, and group policy configurations and core systems operations 

• Experience with zero-trust network design, hybrid cloud security models, and compliance frameworks 

• Certifications such as CCNP, Azure Network Engineer Associate, or equivalent 

#LI-CT1 #LI-Hybrid