Sr. Manager Quality and Risk Management

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA‑approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid‑to‑late‑stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier‑stage programs that address other underserved patient needs.

At Acadia, we're here to be their difference.

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

The Sr. Manager Quality and Risk Management role will be responsible for managing assigned Research and Development (R&D) Quality Risk Management activities at Acadia, including assessment and quality control of Acadia clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP). Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted.

Additionally, candidate will be required to identify emerging issues and compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to (or lead efforts to) their implementation.

• Contribute to effective quality control and QRM of applicable Acadia clinical trial operations, R&D procedures, and related processes.
• Create new appropriate process and/or compliance indicators (semi‑automated metrics and manual spot‑checks) in order to reinforce adherence to internal processes and procedures and to identify areas for improvement. Calculate, track and report such indicators on a continual basis.
• Lead study and program teams to translate R&D risks related to Critical to Quality (critical data quality and subject protection) into KRIs.
• Work in close collaboration with colleagues in Quality, Acadia operational units in Drug Development:
  Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, and vendors (CSPs), to resolve and/or escalate concerns and/or opportunities for improvement that impact GxP activities.
• Where assigned, support study‑specific staff members through the Veeva Quality Management System (QMS) process for Deviation, CAPA and Quality Risk Management.
• Maintain and where needed update aspects of the R&D QRM framework, e.g., internal procedures, processes training modules and tools. Lead the organization through QRM and Risk‑Based Quality Management (RBQM) related changes, e.g., updates from ICH, regulatory guidance and business best practices.
• Ensure the continuous improvement of clinical trial processes and associated SOPs within Clinical Operations, trial monitoring, Data Management and Pharmacovigilance (PV); especially when related to Critical to Quality factors.
• Support or lead the implementation of R&D touching ICH updates (e.g., ICH E6, E8, E9, Q9) and assigned Process Improvement initiatives in R&D, based on QRM and data analysis criteria; identify design efficiencies based on critical study/program and CSP data.
• Contribute to activities related to Health Authority Inspections, and state of inspection readiness for Clinical studies, Pharmacovigilance, and participate in logistical tasks to ensure smooth inspection request flow.
• Support onboarding of other (new) members of the QRC team where applicable.
• Other duties as assigned.

Bachelor's or master's degree in a relevant field (e.g. biology, nursing, neuroscience, psychology, biochemistry, clinical pharmacology, or related). An equivalent…