This position will provide quality oversight of Denali's external manufacturing and laboratory network (CMO/CLOs) and support internal/external CMC development activities. This position will also contribute to establishing the internal quality framework including developing quality documentation and will represent Quality cross functionally within Denali for given project activities.
Key Accountabilities/Core Job Responsibilities: - Oversee 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, disposition of Denali products and audits as needed.
- Oversee product quality aspects of the supply chain and distribution networks from GLP tox batches to Commercial release.
- Establish and support quality systems and operations, including document control, deviation reporting and temperature excursions.
- 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.
- Support efforts to implement and utilize the QMS through the internal electronic document management system and associated eQMS modules.
- Write and approve SOPs and Policies related to compliance and quality.
- Represent Quality on cross functional working groups and projects as required, ensuring the provision of program execution consistent with all regulatory guidance.
- Serve as a back-up to the other technical quality team members to support the CMC and Supplier teams and leadership as required.
- 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: - BS in a scientific discipline; MS preferred; professional certification in quality, compliance and/or regulatory is a plus
- 10 + years of GMP experience in the Pharmaceutical industry.
- 8+ years of management experience
- Experience with CMOs, and CMC development. Large molecule or 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.
- Familiarity with eQMS systems.
- Able to travel domestically and internationally.
Salary Range: $192,000.00 to $249,000.00 . 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/careers
This 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.
