Acadia advances care for underserved neurological disorders and rare diseases. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. Backed by NEA.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
More about this role
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.
This is a hybrid role requiring three days per week onsite and may be based in either our San Diego, CA or Princeton, NJ office
Position Summary
The Sr. Manager, Quality Assurance Compliance will play a key role in supporting Acadia’s growing portfolio by leading internal and external GMP audit activities and maintaining robust quality systems. This position is responsible for ensuring Contract Service Providers (CSPs) and internal operations meet Acadia standards and applicable U.S. and international regulatory requirements,...
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