Senior QA Specialist

Summary:

The Senior QA Specialist will collaborate closely with Veeva SQM users, key stakeholders within the Ultragenyx global network. Looking for a seasoned supplier SME that can play both a strategic role as well as roll up their sleeves as needed. This individual will ideally come from a pharmaceutical or biologics background. This person will have deep expertise in strategic and tactical execution of End-to-End Supplier Quality Management for contract organizations, service providers and materials suppliers (raw, excipients, other). Looking for someone who has a strong background on Supplier Management (not auditing, but more on the qualification process).

This is a Flex to Remote role that will be filled based on individual experience and depending on growing business needs.

Responsibilities:

• Support all Supplier Quality Management processes including generating/reviewing Quality Technical Agreements for suppliers, managing Approved Supplier List, actively working with key stakeholders to ensure supplier compliance, SOP updates etc.
• Deep expertise in strategic and tactical execution of End-to-End Supplier Quality Management
• for contract organizations, service providers and materials suppliers (raw, excipients, other)
• Ability to establish and negotiate Quality Agreements with contract organizations, service
• providers and materials suppliers (raw, excipients, other)
• Ability to coach cross functional internal team members on required risk assessments, audits,
• contracts, and other aspects of ensuring clear oversight of vendors.
• Track, trend, communicate out progress of supplier qualifications
• Support the monitoring of supplier quality metrics
• Support continuous improvement initiatives for the program
• Support site/departmental inspection readiness programs, as needed.
• Provide quality system guidance, support and training for global system users
• Utilize risk management principles to continuously improve current Supplier Quality processes

Requirements:

• Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
• Demonstrated experience managing Vendor Quality Management processes including management of Approved Supplier List, Supplier Notification of Changes, Supplier Corrective Action Requests
• Demonstrated experience with cGMP quality systems, including: Documentation, Change Control, and Deviation/CAPA.
• Experience working with cross-functional teams to complete qualification requirements as
• described by internal processes/procedures.
• Strong collaboration, teamwork, organizational skills and attention to detail
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections a plus. 
• Support a culture of quality and continuous improvement
• GMP knowledge and experience required
• Project management skills
• Veeva QMS experience a strong plus