Senior Manager CSV Quality Systems

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.

At Acadia, we're here to be their difference.

Seeking talent near:
Princeton, NJ.

Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems. Evaluate, propose and implement technology solutions that improve digitization, compliance and productivity. Serve as the CSV subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements. Collaborate with peers across Acadia on procedures relating to quality, data integrity and computer system validation.

• Responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with global regulatory guidelines.
• Provide input into developing scope, actions, and timelines on computer system validation projects and be accountable for implementing and validating computerized systems, including reviewing and approving validation deliverables and change controls.
• Contribute expertise and provide guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessments.
• Collaborate with IT teams, vendors, business users, and internal quality compliance staff to ensure that CSV activities are planned and executed in accordance with internal procedures.
• Partner with IT, quality, and business functional experts on vendor selection and qualification activities for IT services and software providers.
• Evaluate and maintain quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
• Represent quality, compliance and validation controls to cross‑functional business leaders when needed, including managing escalations as needed.
• Ensure quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.
• Provide support for inspection readiness activities.
• Provide oversight and set the strategy for Acadia's approach to data integrity, data governance.
• Perform periodic review analysis of validation documentation, systems and practices.
• Communicate identified gaps, including recommending and implementing corrective actions and improvements.
• Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes.
• Responsible for generating a risk‑based strategy across the GxP landscape that identifies and manages issues and risks related to data integrity as well as a continuous improvement process that assures continuous compliance with global DI standards.
• Identify and define key performance indicators, metrics, and success criteria relevant to DI.
• Other duties as assigned/required.

• Bachelor's degree or equivalent in computer science, engineering, life science or related field.
• A minimum of 5 years of experience in computer systems validation in the pharmaceutical industry, including at least 2 years managing/overseeing computer system validation projects.
• Candidate must be a subject matter expert in computer system validation, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.
• Candidate must be technically conversant in concepts and techniques related to software development and…