Executive Director, CMC QA

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The Executive Director CMC QA will provide strategic operational and technical quality leadership across all Ultragenyx programs inclusive of biologics smallmolecule gene therapy and ASO. This leader will oversee CMC QA responsibilities spanning program QA and CMO QA for starting materials drugsubstance and drugproduct ensuring phase-appropriate and commercially robust quality oversight from development through lifecycle management. The role will lead and develop a team ofapproximately 812 quality professionals partner closely with Technical Operations Product Development Supply Chain Regulatory and Quality stakeholders and represent CMC QA in governance forums inspections regulatory submissions and external partner interactions.

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

1. Set and execute the CMC QA vision strategy operating model and priorities for External Operations across all Ultragenyx programs and modalities including starting materials drugsubstance and drugproduct.
2. Lead coach and develop a high-performing team ofapproximately 812 staff members responsible for program QA and CMO QA oversight;establishclear accountabilities resource plans succession plans and performance expectations.
3. Ensure external partnersoperatein compliance with FDA EMA ICH and other applicable global regulatory requirements Ultragenyx Quality standards approved regulatory filings quality agreements and industry best practices.
4. Drive proactive risk-based oversight of external manufacturing quality systems including deviations investigations CAPAs change controls complaints product impact assessments APR/PQR/APQR CPV validation and tech transfer activities.
5. Own or oversee quality risk management strategies for external operations including risk profiles risk controls escalation pathways quality metrics scorecards trend reviews and continuous improvement plans for CMOs and critical suppliers.
6. Ensure robust CMO and supplier qualificationselection onboarding ongoing monitoring and lifecycle governance in partnership with Technical Operations Supply Chain Regulatory Inspection Management and Quality Systems.
7. Lead and/or support health authority inspection readiness pre-approval inspection readiness CMO inspection support due diligence assessments and responses to inspection observations associated with CMC and external operations.
8. Provide Quality leadership for regulatory submissions and post-approval commitments including review of relevant CMC sections for INDs BLAs MAAs amendments supplements annual reports and responses to health authority questions.
9. Develop implement and continuously improve CMC QA policies SOPs standards governance processes and scalable quality infrastructure to support rare and ultrarare disease product development commercial supply and portfolio growth.
10. Model and reinforce a culture of quality accountability collaboration continuous improvement and patient focus across internal teams and external partners.
11. Perform other duties as assigned.

1. Bachelors degree in life sciences engineering pharmacy chemistry biotechnology ora relateddiscipline; advanced degree (MS PharmD PhD or equivalent) preferred.
2. Typically15 years of progressive experience in pharmaceutical biotechnology biologics gene therapy small molecule or related regulated industry withsignificant experiencein CMC Quality Assurance and external manufacturing oversight.
3. Typically10 years of leadership experience within a Quality organization inaFDA/EMA-regulated environment including experience leading leaders or senior professionals and managing departmental priorities budgets and resources.
4. Demonstrated experience providing quality oversight for CMOs/CDMOs critical suppliers and/or outsourced GMP operations across clinical launch and commercial lifecycle stages.
5. Expert knowledge of global GMP requirements and expectations including FDA EMA ICH Q7/Q8/Q9/Q10/Q11/Q12 as applicable and experience with other regulatory authorities such as MHRA PMDA Health Canada ANVISA and/or other global agencies.
6. Strong technical understanding of CMC development and manufacturing across multiple modalities such as biologics small molecules oligonucleotides gene therapy mRNA enzymes/proteins or other advanced/novel therapeutics; direct experience with starting materials drug substance and drug product preferred.
7. Proven ability to lead CMC QA strategy for rapid development rare disease ultrarare disease registration launch readiness and commercial operations in a matrixed and/or highly outsourced operating model.
8. Demonstratedexpertisein quality agreements supplier qualification deviation/investigation approval CAPA effectiveness change control validation technology transfer APQR/PQR CPV and quality metrics.
9. Experience supporting health authority inspections PAI readiness regulatory filings responses to health authority questions and inspection observation remediation.
10. Strong quality risk management capability andproficiencywith root cause analysis risk assessment trend analysis and decision-making tools.
11. Executive-level communication influencing negotiation and stakeholder-management skills with the ability to align senior leaders and external partners around pragmatic compliant patient-focused solutions.
12. Demonstrated ability to build lead engage and develop high-performing teams through ambiguity growth and organizational change.
13. Experience with Veeva or other electronic Quality Management Systems preferred;proficiencywith Microsoft Word Excel PowerPoint Teams and Project or equivalent tools.
14. Ability to travel up toapproximately 2030% domestically and internationally to Ultragenyx sites CMOs/CDMOs suppliers and regulatory or inspection-related activities as business needs require.

• Primarily office-based role using a computer phone and virtual collaboration tools for extended periods.

• Ability to work in a hybrid environment and travel to Ultragenyx sites external manufacturing partners contract laboratories supplier sites and other business locations as needed.

• Occasional entry into GMP manufacturing warehouse laboratory or controlled environments may require use of personal protective equipment and adherence to site-specific gowning safety and access requirements.
• Ability to sit or stand for extended periods andparticipatein meetings inspections walkthroughs and partner visits.

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