Global Head of Quality & CMC - Biotech Manufacturing

Denali Therapeutics; South San Francisco (CA); On-site; USD 229,000 - 297,000; Full time

Benefits offered by this job

401k

Healthcare

ESPP

Job summary

Denali Therapeutics is seeking a Quality leader to oversee the external manufacturing network (CMOs) for clinical and commercial products. You will review quality documentation, manage batch records, changes and specifications, and ensure compliance across the supply chain. This role requires deep GMP/GLP knowledge and strong leadership.

You will support CMC development, establish SOPs, and prepare for regulatory inspections while mentoring a team and traveling domestically and internationally.

Qualifications

• BS in a scientific discipline; MS preferred.
• 12+ years GMP/GLP experience in pharma.
• CMO, CMC development experience required.
• Strong knowledge of 21 CFR 210–211, Part 11, 610 & 820; cGMP/GLPs and ICH guidelines.
• Experience with electronic QMS/LMS platforms such as Veeva, Master Control, ComplianceWire or equivalent desirable.

Responsibilities

• Oversee GMP and GLP quality operations at CMOs, including review/approval of batch records, changes and specifications.
• Oversee end-to-end product quality management across supply chain and distribution networks; batch release disposition for clinical and commercial products.
• Support CMC development including review/approval of specifications, stability studies, method validation and QC test methods.
• Write and approve SOPs/Policies; provide regulatory inspection readiness and responses to observations.
• Lead direct report(s) through annual goal setting and training compliance.

Skills

GMP experience

People mgmt

CMO experience

CMC development

Regulatory expertise

SOP writing

QMS/LMS tools

ICH guidelines

Travel

Quality systems

Education

BS in scientific discipline

MS preferred

Tools

Veeva

MasterControl

ComplianceWire

Job description

Denali Therapeutics is seeking a Quality leader to oversee the external manufacturing network (CMOs) for clinical and commercial products. You will review quality documentation, manage batch records, changes and specifications, and ensure compliance across the supply chain. This role requires deep GMP/GLP knowledge and strong leadership.

You will support CMC development, establish SOPs, and prepare for regulatory inspections while mentoring a team and traveling domestically and internationally.