Bachelor's degree in Life Sciences or related field, or equivalent experience
Minimum of 6 years in Quality Assurance, with 3 years in GMP Quality Assurance
Experience conducting GMP audits of suppliers and internal operations
Knowledge of U.S. and international GMP regulations, including FDA and ICH
Experience in pharmaceutical or biopharmaceutical operations, including clinical and commercial activities
Responsibilities
Plan and conduct GMP compliance audits of CSPs and internal operations
Prepare and review audit reports, addressing compliance issues
Oversee development and maintenance of Quality Agreements with CSPs
Maintain internal audit program and compile compliance metrics
Prepare and maintain Standard Operating Procedures (SOPs)
Provide compliance expertise for GxP activities and quality systems
Ensure compliance with FDA, EU, and international GMP requirements
Benefits
Competitive base salary and discretionary bonuses
Medical, dental, and vision insurance
Employer-paid life and disability coverage
401(k) Plan with 1:1 company match up to 5%
Employee Stock Purchase Plan with price lock-in
15+ vacation days and 13-15 paid holidays
10 days of paid sick time
Paid parental leave
Tuition assistance
Full Job Description
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, while overseeing Quality Agreements and supporting continuous improvement across GxP operations.
Primary 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
Education and Experience
Bachelor's degree in Life Sciences or a related field, or an equivalent combination of relevant education and experience
Minimum of 6 years of progressively responsible Quality Assurance experience, including at least 3 years of direct GMP Quality Assurance experience
Experience conducting external/supplier 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
Phycical Requirements
While performing the duties of this job, the employee is regularly required to 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. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule and/or business priorities.
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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
Salary Range
$138,000-$172,100 USD
What we offer US-based Employees:
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders. The company's lead product, Nuplazid (pimavanserin), is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA's pipeline includes product candidates for the treatment of schizophrenia, dementia-related psychosis, and major depressive disorder. The company was founded in 1993 and is headquartered in San Diego, California.
