Senior Manager, CMC QA

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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. 

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.

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 

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.  

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