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.
Professional certification in quality, compliance, and/or regulatory is a plus.
Experience with CMOs and CMC development; large molecule and commercialization experience is a plus.
Strong knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH guidelines.
Experience with electronic QMS/LMS platforms such as Veeva or equivalent.
Willingness to travel domestically and internationally.
Responsibilities
Oversee GMP and GLP quality operations at CMOs, including documentation reviews and approvals.
Manage product quality across the supply chain from GLP tox batches to commercial release.
Accountable for batch release disposition for clinical and commercial products.
Support CMC development by reviewing specifications, stability studies, and validation processes.
Establish infrastructure and SOPs for CMC commercial operations and product launches.
Write and approve compliance and quality-related SOPs and policies.
Provide quality expertise for regulatory inspections and responses to observations.
Benefits
401k plan
Healthcare coverage
Employee Stock Purchase Plan (ESPP)
Broad range of other benefits
Full Job Description
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 plus
Experience 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/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.
About Denali Therapeutics
Denali Therapeutics is a biotechnology company focused on developing therapies for neurodegenerative diseases. The company's pipeline includes treatments for Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis (ALS). Denali Therapeutics uses a proprietary technology platform to develop drugs that can cross the blood-brain barrier, which is a major challenge in treating neurological disorders. The company was founded by a team of scientists with extensive experience in drug development and neuroscience research.
