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Acadia Pharmaceuticals

Develops and commercializes CNS disorder therapies

Director – GCP Quality Assurance

Regulatory & Quality (Life Sciences)Updated on Nov 12
Full-time

About the Job

Requirements

  • A bachelor's degree in Life Sciences or a related scientific discipline, or an equivalent combination of education and relevant experience.
  • At least 10 years of experience within the pharmaceutical, biotechnology, or a related regulated industry.
  • At least 5 years of direct experience in GCP Quality Assurance, compliance, and auditing functions.
  • Demonstrated experience serving as a Lead Auditor for internal and external GCP audits.
  • Strong knowledge of ICH-GCP guidelines and applicable FDA, EU, and international GCP regulations.
  • Experience auditing CROs, investigator sites, vendors, and other GCP service providers.
  • Experience supporting regulatory inspections and inspection readiness activities.
  • Ability to interpret and apply global GCP regulations to quality systems and clinical trial operations.
  • Ability to travel independently overnight and work after hours if required by travel schedule or business priorities.
  • Ability to perform duties in a standard office environment and independently from remote locations, including occasionally lifting or moving up to 15 pounds.

Responsibilities

  • Plan, schedule, conduct, and manage internal and external GCP audits of Contract Service Providers, CROs, investigator sites, and supporting vendors to ensure compliance with company standards and global GCP regulations.
  • Prepare, review, and finalize audit reports, ensuring observations, risks, and corrective actions are documented and appropriately tracked to resolution.
  • Lead the development, review, and maintenance of GCP Quality Agreements with CROs, CSPs, and other clinical study partners.
  • Maintain GCP audit metrics and deliver quality and compliance reporting to support management reviews, inspection readiness, and continuous improvement initiatives.
  • Develop, review, and maintain SOPs and quality documents supporting GCP auditing and compliance activities.
  • Manage the internal GCP audit program, including audit planning, execution, follow-up activities, and effectiveness assessments.
  • Support mock inspections, regulatory inspections, and responses related to GCP studies and quality systems.
  • Provide GCP compliance guidance and oversight to cross-functional stakeholders while ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements.
  • Recommend and implement improvements to GCP quality systems, processes, and procedures to strengthen compliance and operational effectiveness.
  • Perform other duties as assigned.

Desired Qualifications

  • SQA, ASQ, or Lead Auditor certification.
  • Experience conducting global audits across the US, EU, UK, Japan, and other international regions.
  • Experience with clinical service providers and supporting functions such as eCOA, computerized system validation (CSV), and data management.

About the Company

Acadia Pharmaceuticals

Develops and commercializes CNS disorder therapies

ACADIA Pharmaceuticals develops and commercializes medicines for central nervous system (CNS) disorders, focusing on neurological and psychiatric conditions with unmet medical needs. Its work centers on identifying drug candidates, advancing them through preclinical and clinical trials, and, upon regulatory approval, bringing therapies to market. Its products address CNS conditions such as Parkinson's disease psychosis, reflecting a commitment to treating complex brain disorders. The company combines in-house research with potential strategic collaborations to expand its portfolio and reach. Unlike peers that rely on a single development path, ACADIA emphasizes a broad pipeline and the ability to commercialize approved therapies, aiming to provide effective CNS treatments to patients and improve outcomes in mental health and neuroscience.

Company size
1,001-5,000
Company stage
IPO
Headquarters
San Diego, CA
Founded
1993

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