Sr. Manager Quality Audit and Compliance

acadiapharmaceuticals; Princeton (NJ); Híbrido; USD 138.000 - 172.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision insurance

401(k) Plan with a fully vested match

Employee Stock Purchase Plan

Vacation and holidays

Tuition assistance

Descripción de la vacante

Acadia Pharmaceuticals in the United States is seeking a Sr. Manager, Quality Assurance Compliance to lead internal and external GMP audit activities and maintain robust quality systems across CSPs and operations.

You will ensure compliance with FDA, EU/EudraLex, ICH and other GMP requirements, oversee Quality Agreements, and drive continuous improvement of GxP processes and documented systems. The role is hybrid with three onsite days weekly and may be based in San Diego, CA or Princeton, NJ

Formación

• Bachelor's degree in Life Sciences or related field.
• Minimum of 6 years of progressively responsible Quality Assurance experience, including at least 3 years of direct GMP QA experience.
• Experience conducting external/supplier and internal GMP audits.
• Working knowledge of U.S. and international GMP regulations (FDA, EU/EudraLex, ICH).
• Experience applying GMP requirements across pharma operations including clinical development, manufacturing, technology transfer, and/or commercial activities.

Responsabilidades

• Plan, schedule, coordinate, and conduct GMP compliance audits of CSPs, suppliers, and internal operations.
• Prepare and review audit reports, evaluate observations and corrective actions.
• Oversee the development, approval, and maintenance of Quality Agreements with CSPs.
• Maintain the internal audit program and compile audit metrics.
• Prepare, review, and maintain SOPs and support continuous improvement of quality systems.
• Provide compliance expertise across GxP activities and required recall/alert processes.
• Ensure quality systems comply with FDA, EU/EudraLex, ICH, and other GMP requirements.
• Provide CSV support for quality system-related computerized solutions.
• Recommend and implement updates to quality policies and procedures.

Conocimientos

GMP audits

Quality Assurance

Regulatory compliance

CSV

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

Quality systems

Computer System Validation (CSV)

Descripción del empleo

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, 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.

Salary Range

$138,000 - $172,100 USD

What we offer US-based Employees

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.

• 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

EEO Statement (US-based Employees)

Studies have shown that women and people of color are less likely to apply for jobs unles

#LI-CS1

#LI-Hybrid