Executive Director, CMC QA

Key facts

Requirements

A bachelor's degree in life sciences, engineering, pharmacy, chemistry, biotechnology, or a related discipline is required; an advanced degree (MS, PharmD, PhD, or equivalent) is preferred.

Typically 15+ years of progressive experience in pharmaceutical, biotechnology, biologics, gene therapy, small molecule, or related regulated industry is required, with significant experience in CMC Quality Assurance and external manufacturing oversight.

Typically 10+ years of leadership experience within a Quality organization in a FDA/EMA-regulated environment is required, including experience leading leaders or senior professionals and managing departmental priorities, budgets, and resources.

Demonstrated experience providing quality oversight for CMOs/CDMOs, critical suppliers, and/or outsourced GMP operations across clinical, launch, and commercial lifecycle stages is required.

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 is required.

A 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 is required; direct experience with starting materials, drug substance, and drug product is preferred.

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 is required.

Demonstrated expertise in quality agreements, supplier qualification, deviation/investigation approval, CAPA effectiveness, change control, validation, technology transfer, APQR/PQR, CPV, and quality metrics is required.

Experience supporting health authority inspections, PAI readiness, regulatory filings, responses to health authority questions, and inspection observation remediation is required.

Strong quality risk management capability and proficiency with root cause analysis, trend analysis, and decision-making tools are required.

Executive-level communication, influencing, negotiation, and stakeholder-management skills are required, with the ability to align senior leaders and external partners around pragmatic, compliant, patient-focused solutions.

Demonstrated ability to build, lead, engage, and develop high-performing teams through ambiguity, growth, and organizational change is required.

Experience with Veeva or other electronic Quality Management Systems is preferred; proficiency with Microsoft Word, Excel, PowerPoint, Teams, and Project or equivalent tools is required.

Ability to travel up to approximately 20-30% domestically and internationally to Ultragenyx sites, CMOs/CDMOs, suppliers, and regulatory or inspection-related activities, as business needs require, is required.

Practical notes

This position is primarily office-based with extended computer, phone, and virtual collaboration tool use. The role operates in a hybrid environment with 2-3 onsite days per week, subject to business needs.

Good to know

External quality assurance roles in rare disease biotechnology typically operate in matrixed environments with extensive collaboration across regulatory, operations, and development functions.

Proficiency with electronic quality management systems and structured document control is common for modern quality functions in regulated industries.

Risk-based oversight, CAPA systems, and validation of processes are standard methods used in pharmaceutical and biotechnology manufacturing quality management.

Health authority inspections and regulatory submission support require precise documentation, cross-functional coordination, and responsiveness to regulatory queries.

Leadership at this level influences global quality strategy, stakeholder alignment, and long-term quality infrastructure for clinical and commercial supply.