Sr. Manager Quality Audit and Compliance

The role

The Sr. Manager Quality Assurance Compliance will lead internal and external GMP audit activities and maintain quality systems. This role ensures Contract Service Providers and internal operations meet company standards and regulatory requirements.

What you will do

• Plan, schedule, coordinate, and conduct GMP compliance audits of CSPs, suppliers, and internal operations
• Prepare and review audit reports and evaluate corrective actions
• Oversee development, negotiation, approval, and maintenance of Quality Agreements
• Maintain the internal audit program and compile audit metrics
• Prepare, review, and maintain Standard Operating Procedures (SOPs)
• Provide compliance expertise across GxP activities
• Ensure quality systems comply with FDA, EU/EudraLex, Canadian, ICH, and other international GMP requirements
• Provide Computer System Validation (CSV) support for quality system-related computerized solutions
• Recommend and implement updates to quality policies and procedures
• Perform other duties as assigned

Required qualifications

• 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
• 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 FDA, EU/EudraLex, and ICH
• Experience applying GMP requirements across pharmaceutical or biopharmaceutical operations
• Ability to stand, walk, sit, use hands, reach, climb, balance, stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations
• Ability to occasionally lift and/or move up to 15 pounds
• Ability to travel independently overnight and work after hours if required

Benefits

• 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 the company

Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. Their commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.