Senior Manager, PV Quality System

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.

Key Accountabilities/Core Job Responsibilities:

• PV Quality, Performance and Compliance Monitoring:

  • Develop, implement, and maintain Pharmacovigilance (PV) quality and performance monitoring systems aligned with global regulatory standards.

  • Ensure efficiency and high quality of PV processes through continuous monitoring and improvements.

  • Continuously monitor and analyze compliance trends and issues, offering comprehensive insights and solutions.

  • Establish and implement relevant compliance Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).

• Support for Regulatory Inspections:

  • Facilitate preparation, support, and process improvements during regulatory inspections and audits.

• System Oversight:

  • Ensure PV systems align with regulatory standards and identify areas for improvement.

  • Collaborate with IT, Safety Operations, and vendors to address system gaps and inefficiencies.

• Training and Development:

  • Design and deliver training programs on PV quality standards, systems, and processes for internal teams and partners.

  • Evaluate training effectiveness and update content to align with industry and regulatory standards.

• Inspection Readiness:

  • Maintain inspection readiness activities and address gaps impacting PV process compliance.

  • Ensure oversight and tracking of country-specific PV regulatory requirements.

• Regulatory Intelligence:

  • Assess the impact of PV regulatory changes and collaborate with experts to ensure compliance.

  • Document outcomes and proposed actions to address regulatory requirements effectively.

• Cross-Functional Collaboration:

  • Work with PV Agreements teams, PV functions, and Quality Assurance to monitor and oversee vendor compliance.

  • Align PV quality goals with Clinical Development, Regulatory Affairs, and Quality Assurance.

  • Ensure consistency with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.

• Communication and Continuous Improvement:

  • Provide updates on quality initiatives, compliance, and training outcomes to senior leadership.

  • Promote a proactive culture of continuous improvement within the PV team.

Qualifications/Skills:

• Bachelor’s degree in life sciences, pharmacy, or a related field; advanced degree preferred. 
  5 years of experience in Pharmacovigilance, with a strong focus on quality management and system oversight. 

• Expertise in global PV regulations, guidelines, and best practices (focusing on GVP, GCP and GMP). Experience with regulatory inspections and PV system audits.  

• Experience with PV systems and tools, including safety databases and reporting systems. 
  Proven track record of contributing to and delivering effective training programs. 

• Strong project management skills, with the ability to support multiple initiatives simultaneously. 

• Excellent communication and collaboration skills, with the ability to work effectively across departments and levels of the organization.  

Preferred Qualifications: 

• Experience with both pre-approval and post-approval PV activities. 

• Previous experience in a similar role within a global pharmaceutical or biotechnology company. 

• Previous experience / Certification in Quality Management or related field. 

Salary Range: $163,000.00 to $210,000.00 .  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 : $163,000 - $210,000