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 Parkinsons 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 Alzheimers disease psychosis and Lewy body dementia psychosis along with earlier-stage programs that address other underserved patient needs. At Acadia were here to be their difference.
Please note that this position is based in San Diego CA or Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.
Position Summary
The Associate Director Quality Operations plays a critical role in ensuring the quality compliance and integrity of Acadias clinical and commercial products. This role provides GMP quality oversight for both internal operations and Contract Manufacturing Organizations (CMOs) across all stages of the product lifecycle. The position partners closely with manufacturing and development teams to support reliable supply regulatory compliance and continuous improvement in alignment with FDA and global GMP requirements.
Primary Responsibilities
Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products
Manage batch review disposition and release activities for drug substance and drug product manufacturing and packaging
Lead QA oversight of technology transfer process validation registration batches deviations and process changes at CMOs
Serve as the primary quality interface with CMOs to ensure compliance with SOPs Quality Agreements and regulatory expectations
Lead investigations change control CAPA activities and risk assessments related to GMP operations
Support complaint handling activities including investigation and closure
Support the design implementation and maintenance of Acadias GMP quality management system in compliance with US and international regulations
Provide on-site GMP quality support at CMOs including participation in audits and inspections as required
Represent Quality Assurance on crossfunctional GMP manufacturing packaging supply chain and development teams
Other duties as assigned
Education/Experience/Skills
Bachelors degree in Chemistry Biology or a related life science
Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry
Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations
Demonstrated experience with US FDA and international GMP regulations
Experience overseeing CMOs and outsourced GMP manufacturing activities
Ability to travel up to 1520%
Physical Requirements
This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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.
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Director
About Acadia PharmaceuticalsAcadia 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 Parkinsons d...
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 Parkinsons 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 Alzheimers disease psychosis and Lewy body dementia psychosis along with earlier-stage programs that address other underserved patient needs. At Acadia were here to be their difference.
Please note that this position is based in San Diego CA or Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.
Position Summary
The Associate Director Quality Operations plays a critical role in ensuring the quality compliance and integrity of Acadias clinical and commercial products. This role provides GMP quality oversight for both internal operations and Contract Manufacturing Organizations (CMOs) across all stages of the product lifecycle. The position partners closely with manufacturing and development teams to support reliable supply regulatory compliance and continuous improvement in alignment with FDA and global GMP requirements.
Primary Responsibilities
Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products
Manage batch review disposition and release activities for drug substance and drug product manufacturing and packaging
Lead QA oversight of technology transfer process validation registration batches deviations and process changes at CMOs
Serve as the primary quality interface with CMOs to ensure compliance with SOPs Quality Agreements and regulatory expectations
Lead investigations change control CAPA activities and risk assessments related to GMP operations
Support complaint handling activities including investigation and closure
Support the design implementation and maintenance of Acadias GMP quality management system in compliance with US and international regulations
Provide on-site GMP quality support at CMOs including participation in audits and inspections as required
Represent Quality Assurance on crossfunctional GMP manufacturing packaging supply chain and development teams
Other duties as assigned
Education/Experience/Skills
Bachelors degree in Chemistry Biology or a related life science
Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry
Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations
Demonstrated experience with US FDA and international GMP regulations
Experience overseeing CMOs and outsourced GMP manufacturing activities
Ability to travel up to 1520%
Physical Requirements
This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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.
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