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
- Represent department on cross site projects
- 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
Skills / 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
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About UsWhy 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.
Skills Required
- 6+ years of experience in a pharmaceutical quality function
- Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
- Quality assurance experience in pharmaceutical product development and early-phase clinical trial expectations
- Broad quality experience, preferably including manufacturing operations, API and drug product release, method development, method validation and transfer, QP release, and process validation
- Strong troubleshooting and problem-solving ability
- Proficiency in risk assessment tools
- Ability to plan, organize, and prioritize work effectively
- Bachelor's degree in a scientific discipline or related field
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
