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Acadia Pharmaceuticals

Develops and commercializes CNS disorder therapies

Senior Manager Quality Audit and Compliance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in Life Sciences or a related field, or an equivalent combination of relevant education and experience.
  • At least 6 years of progressively responsible Quality Assurance experience, including at least 3 years of direct GMP Quality Assurance experience.
  • Experience conducting external or supplier audits and internal GMP audits, including audits or inspections of manufacturing facilities.
  • Working knowledge of U.S. and international GMP regulations and quality requirements, including applicable FDA, EU/EudraLex, and ICH requirements.
  • Experience applying GMP requirements across relevant pharmaceutical or biopharmaceutical operations, including clinical development, manufacturing, technology transfer, and/or commercial activities.

Responsibilities

  • Plan, schedule, coordinate, and conduct GMP compliance audits of Contract Service Providers (CSPs), suppliers, and internal operations in accordance with company standards and applicable domestic and international regulations.
  • Prepare and review audit reports, evaluate observations and corrective actions, and ensure identified compliance issues are appropriately addressed.
  • Oversee the development, negotiation, approval, and maintenance of Quality Agreements with clinical and commercial CSPs.
  • Maintain the internal audit program and compile audit metrics and compliance trends to support Management Review and quality system oversight.
  • Prepare, review, and maintain Standard Operating Procedures (SOPs) and support continuous improvement of quality systems in accordance with current GMP requirements and industry standards.
  • Provide compliance expertise across GxP activities, including annual product reviews, mock recalls, field alerts, actual recalls, and quality system-related computerized solutions.
  • Ensure quality systems, procedures, and processes comply with applicable FDA, EU/EudraLex, Canadian, ICH, and other international GMP requirements.
  • Provide Computer System Validation (CSV) support for quality system-related computerized solutions, as needed.
  • Recommend and implement updates to quality policies and procedures based on evolving regulations, compliance trends, and business requirements.
  • Perform other duties as assigned.
  • Stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, see, talk, or hear in a standard office environment and independently from remote locations.
  • Occasionally lift and/or move up to 15 pounds.
  • Travel independently overnight and work after hours if required by the travel schedule and/or business priorities.

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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