Senior Manager, QC for QA

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

Provide analytical and QC support within the Quality Group, overseeing GMP quality operations for internal and external activities, including documentation reviews and approvals. Support product disposition, supplier qualification, quality audits, and establish quality systems such as document control, CAPA, and deviation management.

Key Accountabilities/ Core Job Responsibilities

• Provide Analytical and QC support within the Quality Group.

• Oversee GMP Quality operations for internal and external operations, with a focus on QC activities, including quality documentation reviews and approvals.

• Assist the disposition of Denali products.

• Support supplier qualification and quality audits for Denali sites including Contract Manufacturing Organizations and Contract Test Labs as needed.

• Establish and support quality systems and operations, including document control, change controls, deviation, CAPA, effectiveness checks and temperature excursions.

• Support CMC development and commercial operations, including review and approval of QC specific documentation including Certificate of Analysis, specifications, stability studies, method validation, test methods, process validation and all associated QC data.

• Support and review relevant sections of IND/IMPD/BLA

Qualification/Skills

• Bachelor’s degree in a scientific discipline.

• 5 years of Analytical Development and or QC GMP experience in the Biotech/Pharmaceutical industry. 

• Experience with CMOs, CMC development with focus on both large and small molecules.

• Experience of releasing or supporting release of clinical or commercial drug substance & drug product.

• Current and strong working knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH quality and development guidelines.

• Current and strong working knowledge of Out of Specification Investigations.

• Driven, results-oriented self-starter and excellent team player.

• Able to travel domestically and internationally.

Salary Range: $162,000.00 to $192,333.00 .  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.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.
 

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.

Salary : $162,000 - $192,333