Ultragenyx Pharmaceutical
Healthcare
SeniorManager,CMCQA
“Senior Manager, CMC QA at Ultragenyx Pharmaceutical. Skills: Product Complaints, Annual Product Quality Review, CMC Change Control Review Board, QA Manufacturing Operations, GxP regulations. Responsible for the Product Complaints, Annual Product Quality Review and CMC Change Control Review Board programs. Maintain strategic responsibility over QA Manufacturing Operations”
What You'll Achieve.
leading the future of rare disease medicine; advancing our field so more patients and caregivers can benefit from life-changing treatments; making innovative medicines at fair and reasonable prices; creating a collaborative ecosystem to reach patients in ways that are most meaningful for them; creating a supportive and inclusive environment of profound learning and growth; increasing both efficiency and quality output from all processes
Industry & Context.
analytical and systematic thinking
Travel up to 10% of total work hours
What They're Looking For.
Must Have
Bachelor's degree or equivalent work experience in QA Manufacturing Operations or related discipline, 8+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality, Experience with management of Change Control process and Review Board, Experience with Product Disposition, Expert knowledge of GMPs
Nice to Have
Experience with Product Complaint handling, investigations, and reporting a plus
What You'll Do.
Responsible for the Product Complaints
Annual Product Quality Review and CMC Change Control Review Board programs
Maintain strategic responsibility over QA Manufacturing Operations
Implement and communicate Ultragenyx’s CMC quality approach
Direct and oversee operations in accordance with GxP regulations and Ultragenyx standards
Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC Lead
UGX Change Control Review Board program and provide coaching to Change Owners on the Change Control process as needed
Support the release of production lots in accordance with Ultragenyx procedures
Execution of Quality Systems in an Owner/SME or QA role
Change Controls and Product Quality Complaints
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
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
Support the Product Complaints function in investigating reported product quality events
Represent Ultragenyx to Health Authorities during inspections
Ensure activities and deliverables comply with FDA
EMA and local regulations and guidance
SOPs and industry best practices
Communicate and promote a culture of quality and operational excellence
How You'll Work.
Team & Collaboration
in partnership with Quality Leads; collaboration with Tech Ops and Reg CMC Lead; provide coaching to Change Owners; cross-functional partners
Communication Scope
Communicate and promote a culture of quality and operational excellence
Process & Methodology
Continuous Improvement initiatives and projects
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