Based in Salt Lake City (SLC), the Senior Manager, Quality Assurance (QA) will drive quality assurance defined strategies and objectives for a new large molecule drug substance clinical and commercial manufacturing facility. This includes manufacturing and analytical testing operations, ensuring compliance with FDA, EMA, and global regulatory requirements. This role manages a team responsible for key quality systems including quality on the floor, batch disposition, quality events, GMP documentation and validation.. The position also partners with Manufacturing, QC, and CMC teams to maintain product quality, data integrity, and inspection readiness. The Senior Manager, QA also drives continuous improvement and fosters a strong culture of GMP compliance and operational excellence.

Key Accountabilities / Core Responsibilities

• Lead, mentor, and develop a team of quality professionals, fostering a strong culture of GMP compliance, accountability, and continuous improvement.  

• Provide strategic leadership to strengthen site quality systems and elevate overall regulatory compliance across manufacturing and testing operations.

• Provide quality oversight for GMP manufacturing and QC laboratory operations to ensure adherence to FDA, EMA, and global regulatory standards.  Includes ~ 15%+ spent “on the floor” providing guidance and oversight.

• Review and approve batch records and supporting documentation to support timely and compliant batch disposition and product release.

• Lead and oversee the management of quality events, including deviations, investigations, CAPA, and change controls to ensure effective root cause analysis and corrective actions.

• Maintain hands-on leadership and subject matter expertise in GMP quality operations, ensuring effective implementation and continuous improvement of the QMS.

• Provide quality oversight for qualification and validation activities, including process validation, equipment qualification, and validation lifecycle management.

• Oversee site GMP documentation review and approval.

• Partner cross-functionally with Manufacturing, Quality Control, Validation, and Regulatory teams to drive quality operations, inspection readiness, and continuous process improvement.

• 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.

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Qualifications/Skills:

• Bachelor’s degree in a core scientific discipline

• Typically 8+ years of overall work experience, to include 3+ years in Biotech Manufacturing / Quality and 3+ years people management experience

• Familiarity with large molecule drug substance GMP manufacturing and testing

• Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance

• Ability to work independently or in team environments under deadlines

• Excellent verbal and written communication skills

• Ability to closely follow quality standards and company quality expectations

• Strong collaboration and influencing skills

• Strategic thinking combined with excellence in execution

• Ability to learn quickly, driven by high curiosity

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 athttps://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.