Senior Manager, Quality Assurance (QA)

Denali Therapeutics•Salt Lake City, UT

9d•Onsite

About The Position

Denali Therapeutics is seeking a Senior Manager, Quality Assurance (QA) for its new large molecule drug substance clinical and commercial manufacturing facility in Salt Lake City (SLC). This role is crucial for driving quality assurance strategies and objectives, ensuring compliance with FDA, EMA, and global regulatory requirements for manufacturing and analytical testing operations. The position involves managing a team responsible for key quality systems, including quality on the floor, batch disposition, quality events, GMP documentation, and validation. It also requires close collaboration with Manufacturing, QC, and CMC teams to maintain product quality, data integrity, and inspection readiness, while fostering a strong culture of GMP compliance and operational excellence.

Requirements

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

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.