Sr. Manager

Description:

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