Sr. Manager Quality and Risk Management

Role Summary

The Sr. Manager, Quality and Risk Management will oversee R&D Quality Risk Management activities in a Good Clinical Practices (GCP) regulated environment. This role includes assessment and quality control of Acadia clinical trials, with support in Drug Safety and Pharmacovigilance, Computer System Validation and GLP. It requires close collaboration with internal R&D teams and contract service providers to identify emerging issues and compliance risks, measure performance metrics, and lead or contribute to improvements in trial-related processes and procedures. Location options include San Diego, CA; San Francisco, CA; or Princeton, NJ, with a hybrid model requiring in-office work three days per week.

Responsibilities

• 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) 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.

Qualifications

• Required: Bachelor’s or Master’s degree in biology, nursing, neuroscience, psychology, biochemistry, clinical pharmacology, or related field, or an equivalent combination of education and applicable job experience.
• Required: Minimum of 6 years of R&D focused pharmaceutical/health care experience in a GCP regulated environment, including experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority regulations.
• Required: Experience in a matrix team environment and involvement in continuous improvement projects.
• Required: Strong knowledge of GCP, including quality management and performance metrics; experience with Root Cause Analysis and CAPA development.
• Required: Experience with drug development processes, including clinical protocol development, global trial management, site management and monitoring, drug safety, biostatistics and/or data management.
• Required: Experience with multiple IT programs and systems (e.g., Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office with advanced Excel skills, quality workflow systems).
• Required: Excellent verbal and written communication; able to work independently and in cross-functional teams.
• Required: Proactive, interpersonal, problem-solving and conflict-resolution skills.
• Required: Flexibility to switch between projects and assignments; ability to manage multiple projects and work streams daily.
• Required: Ability to interpret and apply practical knowledge of regulations and guidelines for immediate resolution of compliance issues and proactive management of GCP and PV quality risks (may be under supervision).
• Required: Ability to assess regulatory/compliance risk, identify areas for improvement and propose practical solutions.
• Required: Ability to work effectively with business partners and management and appropriately signal and escalate matters of significance to the organization.
• Preferred: Knowledge of GLP, GCP and Pharmacovigilance, FDA, EMA/MHRA and ICH regulations.
• Preferred: Experience with organizational change management and promoting a culture of quality.
• Preferred: Experience working in hybrid/remote environments across time zones and cross-cultural teams.
• Preferred: Experience with QA audits and Health Authority inspections by FDA, EMA, MHRA, and PMDA.
• Preferred: Past work at a CSP or CRO in clinical data and/or QRM.
• Preferred: Experience with data visualization software (Power BI, Spotfire, Tableau, etc.).
• Preferred: Familiarity with CNS therapeutic areas and/or Rare Diseases.

Skills

• Strong knowledge of GCP, quality management and performance metrics; experience with Root Cause Analysis and CAPA development.
• Experience with drug development processes, including clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management.
• Experience with multiple IT programs and systems, including CTMS, eTMF, eCRFs, Microsoft Office (advanced Excel), and quality workflow systems.
• Excellent communication skills, both verbal and written; ability to work independently and in cross-functional teams.
• Proactive, interpersonal, problem-solving and conflict-resolution skills.
• Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities daily.
• Ability to interpret and apply practical knowledge of regulations and guidelines for immediate resolution of compliance issues and pro-active management of GCP and PV quality risks, including risk mitigation (under supervision if needed).
• Ability to assess regulatory/compliance risk, identify areas for improvement and propose practical solutions.
• Skilled at working effectively with business partners and management and appropriately signal and escalate matters of significance to the organization.