Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Director, CMC Quality Control – Small Molecules is responsible for providing technical and strategic oversight of all outsourced QC activities supporting Ultragenyx small molecule drug substance and drug product programs across development and commercialization. This position reports to the Executive Director, CMC‑QC. The role leads QC governance for contract manufacturing organizations (CMOs), contract laboratories (CLs), and other external partners, ensuring compliant, phase‑appropriate, and inspection‑ready execution. QC testing experience supporting rare and ultra‑rare disease development models—characterized by lean organizations, accelerated timelines, and high reliance on outsourced partners—is a strong asset. Experience with biologics QC is considered an additional advantage, particularly for candidates supporting hybrid portfolios in a virtual QC model.

Work Model:

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

Responsibilities:

1. Outsourced QC Oversight
   Provide end‑to‑end QC oversight for a 100% outsourced operating model, supporting small molecule drug substance and drug product programs across clinical and commercial stages.
2. CMC QC Leadership – Small Molecules
   Provide technical and strategic leadership for small molecule QC, including solid oral dosage forms and sterile parenterals, with hands‑on oversight of analytical testing, method validation, investigations (deviations, OOS), CAPAs, and lifecycle management in compliance with ICH/USP/Ph. Eur./JP requirements.
3. Analytical & Contract Laboratory Oversight
   Perform technical review and approval of outsourced analytical data, method validation, stability programs, reference standards, specifications, and shelf‑life assignments, ensuring phase‑appropriate QC strategies and data integrity.
4. External Partner & CMO/CL Management
   Lead the selection, qualification, and performance management of CMOs and contract laboratories, serving as the QC technical representative during manufacturing campaigns and managing quality agreements, scopes of work, and issue resolution.
5. Cross‑Functional & Regulatory Engagement
   Collaborate cross‑functionally and lead CMC QC contributions to regulatory submissions, inspections, and audits, including authoring and defending QC sections and managing responses to health authority observations.
6. Oligonucleotide Biologics QC (Advantage) - Provide QC oversight or strategic input for biologics and/or oligonucleotide programs, including analytical methods, stability, and regulatory interactions, as needed.
7. Lead selection, qualification, onboarding, and ongoing performance management of contract laboratories and QC service providers, including governance models, KPIs, and issue escalation.
8. Act as the QC representative in cross‑functional CMC teams, collaborating closely with Technical Operations, Analytical Development, QA, Regulatory Affairs, Supply Chain, and Program Management.
9. Lead QC support for regulatory inspections and audits involving CMOs and CLs; author and manage responses to QC‑related observations and commitments.

Requirements:

1. Education & Experience
   Bachelor’s degree with 14+ years or Master’s degree with 10–12+ years, or PhD with 8–10+ years of relevant GMP experience in chemistry, pharmaceutical sciences, biochemistry, or a related discipline.
2. CMC QC Experience – Small Molecules
   Minimum 5–8+ years of direct CMC QC experience supporting small molecule drug substance and drug product, including commercial assets.
3. Analytical Technical Expertise
   Demonstrated hands‑on expertise with small molecule analytical techniques, including HPLC/UPLC, LC‑MS, GC, dissolution, Karl Fischer, particle size, residual solvents, impurity profiling, and compendial safety testing.
4. Regulatory & Compliance Knowledge
   Strong working knowledge of ICH, FDA, EMA, USP, and Ph. Eur. requirements applicable to small molecule development and commercialization.
5. Outsourced QC & Vendor Oversight
   Proven experience overseeing external QC laboratories, CMOs, and contract testing organizations, including technical governance and performance management.
6. Regulatory Submissions & Inspections
   Experience supporting global regulatory submissions and health authority inspections, including defense of outsourced QC data.
7. Rare & Ultra‑Rare Disease Experience (Asset)
   Quality control experience working within rare and/or ultra‑rare disease development models, including lean organizations, accelerated timelines, and high reliance on outsourced partners, is a strong asset.
8. AI & Digital Enablement (Asset)
   Experience applying digital, automation, and/or AI‑enabled solutions within QC or CMC environments, such as analytical data review, trend analysis, stability modeling, data integrity monitoring, or outsourced partner performance management, is a strong asset.

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