Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Senior Director, External Quality Operations role.
Rezi rewrites your resume against Denali Therapeutics's job description. Free.
Tailor your resume to this Senior Director, External Quality Operations role.
Rezi rewrites your resume against Denali Therapeutics's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Senior Director, External Quality Operations posting at Denali Therapeutics — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Senior Director, External Quality Operations posting at Denali Therapeutics — free, in seconds.
About the Role
This position will provide quality oversight of Denali’s external manufacturing network (CMO), supporting batch release, investigations, change management, and documentation for outsourced project activities.
Responsibilities
- Oversee GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals from Manufacturing and Quality Control.
- Oversee end-to-end product quality management across the supply chain and distribution networks.
- Accountable for batch release disposition across the clinical and commercial product portfolio.
- Support CMC development including review and approval of specifications, stability studies, method validation, QC test methods, process validation, and material distribution activities.
- Support CMC commercial operations including establishing infrastructure, SOPs, and execution for Product Launch activities.
- Write and approve SOPs and Policies related to compliance and quality.
- Provide Quality expertise for regulatory inspections, inspection-readiness activities, and responses to regulatory observations.
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance, and provide ongoing feedback.
Requirements
- Typically requires a BS in a scientific discipline (MS preferred) with 12+ years of GMP experience in the Pharmaceutical industry.
- 10+ years of coaching, mentoring, and direct people management experience.
- Experience with CMOs and CMC development.
- Current and strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
- Able to travel domestically and internationally.
Skills
- Quality oversight
- Batch release
- Investigations
- Change management
- Documentation
- GMP
- GLP
- Quality documentation reviews
- Product quality management
- Supply chain management
- Distribution networks
- CMC development
- Specifications
- Stability studies
- Method validation
- QC test methods
- Process validation
- Material distribution
- CMC commercial operations
- Product launch
- SOP writing
- Policy writing
- Regulatory inspections
- Inspection readiness
- Regulatory observation response
- People management
- Coaching
- Mentoring
- BS in a scientific discipline
- MS preferred
- Pharmaceutical industry experience
- Large molecule experience
- Commercialization experience
- Electronic QMS/LMS platforms (Veeva, Master Control, ComplianceWire or equivalent desirable)
Location
- Domestic
- International
Work Type
- Full-time
Experience Level
- 12+ years of GMP experience
- 10+ years of coaching, mentoring and direct people management experience
Education Level
- BS in a scientific discipline
- MS preferred
Salary/Compensations
- $229,000.00 to $297,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
- Broad range of other benefits
About the Company
- Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform.
- With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
Equal Opportunity
- Denali is committed to its core company value of unity by creating a diverse and inclusive environment.
- We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.