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.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The QA Manager will report to the Sr. Director, Quality in Salt Lake City. This position will primarily drive quality assurance defined strategies and objectives for a new large molecule drug substance clinical manufacturing facility. This position will develop processes and procedures for the SLC Quality Assurance and supporting functions. Additionally, routine review of cGMP documentation following Good Documentation Practices (GDP) to support batch release activities and health authority filings.
Primary Responsibilities and Essential Functions:
- Provide QA support to all site GMP Operations, including manufacturing, Quality Control and Warehouse Operation.
- Support implementation of Quality Management System (QMS) processes including change control, d
- Deviation, document control, and CAPA
- Execute and manage required change controls, deviation, document change and CAPA processes
- Document and report product or service-related quality events
- Support the development and implementation of standard operating procedures, policies and work instructions for processes governing quality services throughout the manufacturing facility and warehouse
- Support the development of raw material chemical and consumable standards for inspection
- Review data compilations (stability, batch analyses, environmental monitoring, etc.) and approve as required
- Author and/or review documentation for product release including, inventory verifications, batch record review, investigations, change control, laboratory reports, validation protocols and reports, calibration documentation and batch summary reports
- Provide document reviews or input for quality or other external functions, in a constructive team-oriented manner with urgency and a continuous improvement perspective
- Clear, collaborative, and effective communication to discuss quality requirements with internal and external Denali partners including, manufacturing operations, MSAT, engineering, facilities, QC, warehouse, Corporate QA, and TechOps teams
- Additional activities assigned or required as directed
- At least 10 years in clinical cGMP pharmaceutical Quality Assurance.
- Working knowledge of cGMP computer system solutions (MasterControl, LabWare LIMS, Netsuite preferred)
- Familiarity with large molecule drug substance manufacturing
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- Ability to effectively collaborate in a dynamic, fast paced, multidisciplinary team environment.
- Ability to work independently or in team environments under deadlines
- Excellent verbal and written communication skills
- Familiar with compliant database management and data integrity principles
- Ability to consistently identify mistakes and maintain a keen eye for detail
- Ability to closely follow quality standards and company quality expectations
- BS/MS in core science discipline
Preferred Additional Skills:
- Proficiency with MS Office, Smartsheet’s, quality system databases, electronic document management.
- Committed to Denali values of growth, unity, grit and trust as well as values related to accountability, transparency, and scientific rigor.
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 Range: $130,000.00 to $156,667.00. 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.