Senior Manager, Quality Assurance (QA)

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.
• 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.
• Lead cross-functional teams to drive quality operations, inspection readiness, and continuous process improvement.
• 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.

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 and Benefits

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.