Senior Director, External Quality Operations

Denali Therapeutics; South San Francisco (CA); Presencial; USD 229.000 - 297.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k

Healthcare

ESPP

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP experience

People mgmt

CMO experience

CMC development

Regulatory expertise

SOP writing

QMS/LMS tools

ICH guidelines

Travel

Quality systems

Educación

BS in scientific discipline

MS preferred

Herramientas

Veeva

MasterControl

ComplianceWire

Descripción del empleo

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.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.This position will provide quality oversight of Denali’s external manufacturing network (CMO). This position will also support batch release, investigations, change management and documentation for given outsourced project activities.Key Accountabilities/Core Job Responsibilities :Oversee both clinical and commercial GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals, from Manufacturing and Quality Control, such as batch records, change controls and specifications of Denali products.Oversee end to end product quality management across the entire supply chain and distribution networks from GLP tox batches to Commercial release.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 on growth, development and areas of improvement.Qualifications/Skills :Typically requires a BS in a scientific discipline (MS preferred) with 12+ years of GMP experience in the Pharmaceutical industry, including 10+ years of coaching, mentoring and direct people management experience.A professional certification in quality, compliance and/or regulatory is a plusExperience with CMOs, and CMC development. Large molecule and commercialization experience is a plus.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.Experience with electronic QMS/LMS platforms such as Veeva, Master Control, ComplianceWire or equivalent desirable.Able to travel domestically and internationally.Salary Range: $229,000.00 to $297,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careersThis compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.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.