Ultragenyxpharmaceutical

Executive Director, CMC QA

Novato, CA; South San Francisco, CA · Director

Sponsorship not specifiedDetected 13 days ago
Supply ChainGMPFDA RegulatoryCRISPRLeadershipCollaboration

About the role

  • The Executive Director, CMC QA will provide strategic, operational, and technical quality leadership across all Ultragenyx programs inclusive of biologics, small molecule, gene therapy, and ASO.
  • This leader will oversee CMC QA responsibilities spanning program QA and CMO QA for starting materials, drug substance, and drug product, ensuring phase-appropriate and commercially robust quality oversight from development through lifecycle management.
  • Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs.

Responsibilities

  • Lead, coach, and develop a high-performing team of approximately 8 -12 staff members responsible for program QA and CMO QA oversight
  • Ensure external partners operate in compliance with FDA, EMA, ICH, and other applicable global regulatory requirements, Ultragenyx Quality standards, approved regulatory filings, quality agreements, and industry best practices.
  • 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.
  • 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.
  • 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.
  • Model and reinforce a culture of quality, accountability, collaboration, continuous improvement, and patient focus across internal teams and external partners.
  • Perform other duties as assigned.
  • Lead, coach, and develop a high-performing team of approximately 8 -12 staff members responsible for program QA and CMO QA oversight; establish clear accountabilities, resource plans, succession plans, and performance expectations.

Nice to have

  • advanced degree (MS, PharmD, PhD, or equivalent) preferred.
  • Bachelor's degree in life sciences, engineering, pharmacy, chemistry, biotechnology, or a related discipline

Compensation

  • 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.

Benefits

  • To achieve this goal, our vision is to lead the future of rare disease medicine.
  • For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
  • We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work.
  • Set and execute the CMC QA vision, strategy, operating model, and priorities for External Operations across all Ultragenyx programs and modalities, including starting materials, drug substance, and drug product.

Company info

  • At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.
Apply directly at Ultragenyxpharmaceutical →Create a free account for alerts like thisView Ultragenyxpharmaceutical immigration profile

This listing is sourced directly from Ultragenyxpharmaceutical's careers page and normalized into a canonical job model.