Senior Quality Assurance Associate II

Alkermes; Cincinnati (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Alkermes is seeking a senior quality professional to oversee pharmaceutical quality functions across API and drug product operations at our U.S. site. You will ensure cGMP compliance, lead QA activities with CMOs, and mentor QA staff while supporting regulatory submissions.

The role emphasizes risk management, investigations, and continuous improvement of quality systems to maintain product integrity and regulatory readiness across multiple development stages.

Qualifications

• 6+ years in a pharmaceutical quality function.
• Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements.
• QA experience in pharmaceutical product development and early phase trials.
• Broad quality experience across manufacturing operations, API and drug product release, method development/validation and transfer, QP release, process validation.
• Strong ability to troubleshoot and problem solve.
• Experience using risk assessment tools.
• Ability to effectively plan, organize and prioritize work.

Responsibilities

• Interface with contract manufacturing organizations (CMOs) including oversight of ongoing CMO activities vs. Alkermes Quality policies and cGMPs; review batch documentation, deviations, investigations, and change controls.
• Facilitate and interact with QP for review and release process.
• Maintain and enhance quality systems to ensure conformance to Alkermes quality practices and regulatory requirements.
• Monitor quality indicators highlighting trends and risks.
• Lead and/or support investigations into variances and quality issues and ensure proper changes to guarantee continued and consistent product quality.
• Promote GMPs.
• Provide QA representation, guidance, leadership, and direction to product development teams across API, drug product, and labeling/packaging operations.
• Identify and evaluate quality, technical and product development issues.
• Provide mentoring to QA Associates and provide feedback to CMO as appropriate.
• Review regulatory documentation and submissions.

Skills

Quality Assurance

Regulatory Knowledge

Problem Solving

Planning & Prioritizing

Education

Bachelor’s degree in scientific discipline

Job description

Responsibilities

• Primary interface with contract manufacturing organizations including oversight of ongoing CMO activities vs. Alkermes Quality policies and cGMPs. Oversight responsibilities include review of batch documentation, deviations, investigations, and change controls
• Facilitate and interact with QP for review and release process
• Maintenance and enhancement of quality systems to ensure conformance to Alkermes quality practices and international regulatory compliance requirements
• Monitor quality indicators highlighting trends and risks
• Independently lead and/or support investigations into variances and quality issues and able to assure that proper changes are made to guarantee continued and consistent product quality
• Proactively promote GMPs
• Provide quality assurance representation, guidance, leadership, and direction to product development teams for two or more different operations which include; API/drug substance, drug product and labeling/packaging operations
• Identify and evaluate quality, technical and product development issues
• Provide guidance/mentoring to QA Associates and cross functionally and provide performance feedback to CMO as appropriate
• Review of regulatory documentation and submissions

Qualifications

• 6+ years of experience in a pharmaceutical quality function
• Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
• QA Experience in pharmaceutical product development and expectations for early phase clinical trials
• Broad quality experience, preferably including manufacturing operations, API and drug product release, method development, method validation and transfer, QP release, process validation.
• Strong ability to troubleshoot and problem solve
• Demonstrated proficiency in use of risk assessment tools
• Ability to effectively plan, organize and prioritize work

Education

• Bachelor’s degree in a scientific discipline or related field

About Us

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.