Full-Time

Director Quality Audits & Compliance

Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc.

501-1,000 employees

Develops therapies for central nervous system disorders.

Biotechnology

Senior, Expert

Princeton, NJ, USA

Required Skills
Sales
Management
Marketing
Requirements
  • Bachelor's degree in a scientific field or related field; MBA preferred.
  • 10 years of progressive responsibility in the biopharmaceutical industry.
  • Extensive knowledge of GLP/GCP audits and compliance applicable to Global GCP and GLP regulatory requirements.
  • Experience with clinical development and subsequent commercialization of at least one product, small molecule preferred.
  • Experience with clinical and regulated non-clinical audit.
  • Strong acumen and demonstrated ability in GLP/GCP auditing, FDA and EMEA regulations inclusive of direct experience with Pharmacovigilance and System Development Life Cycle activities.
  • Knowledge of applicable GCP and GLP domestic and international regulations and guidelines for clinical trials.
  • Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance.
  • Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions.
  • Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs, Drug Safety and Pharmacovigilance, Legal, Commercial, Sales and Marketing, etc.
  • Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the organization.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
  • Ability to travel 30% of the time.
Responsibilities
  • Plan, execute and complete the audit program based on risk assessment for all clinical trials, CROs, vendors, critical computerized systems and internal processes for ensuring adequate sponsor oversight in compliance with GCP regulation and guidelines.
  • Audit activities include all aspects of planning, conducting, reporting, observations follow up and procedural documentation associated with internal and external audits and resource planning necessary to complete all audits.
  • GCP, and GLP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
  • Support regulatory inspections including, but not limited to, FDA, EMA, and other regulatory bodies as Provides management with updates and status responses to regulatory inspections.
  • Will act as a representative to the clinical operations team and other development teams to ensure compliance with applicable regulations and industry guidance.
  • Manage and lead audit and quality systems for GCP/GLP functions including resource planning, budgeting and forecast support.
  • Other duties as assigned.

Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc.

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Acadia Pharmaceuticals Inc. stands out as a leader in the healthcare industry with over 25 years of experience, particularly noted for developing the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. The company's culture is characterized by a dedicated team of "care-ageous warriors" who are committed to improving the lives of patients and their families. Acadia's competitive edge lies in its robust late-stage development efforts focused on dementia-related psychosis, negative symptoms of schizophrenia, and Rett syndrome, as well as early-stage clinical research exploring novel approaches to pain management, cognition, and neuropsychiatric symptoms in central nervous system disorders.

Company Stage

IPO

Total Funding

$813.4M

Headquarters

San Diego, California

Founded

1993

Growth & Insights
Headcount

6 month growth

7%

1 year growth

21%

2 year growth

22%