Sr. Manager Quality and Risk Management

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

Position Summary

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.

Primary 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) in order to reinforce adherence to internal processes and procedures and to identify areas for 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.

Education/Experience/Skills

Bachelors or masters degree in a relevant field (e.g. biology nursing neuroscience psychology biochemistry clinical pharmacology or related). An equivalent combination of relevant education and applicable job experience may be of 6 years R&D focused pharmaceutical/Health Care experience in a GCP regulated environment including some experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority in a matrix team environment and involvement and contribution to continuous improvement projects.

Key Skills

• Strong knowledge of GCP including affinity with quality management and performance metrics and experience with Root Cause Analysis and CAPA development.
• Experience with drug development process including affinity with 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 but not limited to Clinical Trial Management systems eTMF eCRFs Microsoft Office (including above average Excel skills) quality workflow systems.
• Excellent communication skills both verbal and written. Able to work independently as well as in cross-functional teams.
• Excellent pro-active interpersonal problem-solving conflict resolving 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 the immediate resolution of compliance issues and the pro-active management of GCP and PV quality risks including risk mitigation under supervision if needed.
• Ability to assess regulatory/compliance risk identify areas of 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.
• Ability to travel up to 20% of the time.

Desired:

• Knowledge of GLP GCP and Pharmacovigilance FDA EMA/MHRA and ICH regulations.
• Experience with organizational change management especially as it relates to embracing and promoting a culture of quality.
• Experience with working in a hybrid/remote environment cross culturally and across time-zones
• Experience with multi-sized organizations from start-up to large employers.
• Experience with QA audits and Health Authority Inspections by FDA EMA MHRA and PMDA.
• Past work experience at a CSP or CRO in clinical data and/or QRM field is a big plus.
• Experience with data visualization software such as (Microsoft Power BI Spotfire Tableau etc.)
• Familiarity with Central Nervous System (CNS) therapeutic area and/or Rare Diseases is highly desired.

#LI-Hybrid #LI-SL1

Required Experience:

Manager