This function is responsible for managing workflow within and outside Development and External QA. This function resolves and supports day to day events between internal (Alkermes) and external (CMO) stakeholders. This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside the area of responsibility. Minimal travel required to support job function (potential for one trip per quarter in a year).
Responsibilities- Participates as appropriate in management of processes for quality and compliance. Supports the development and maintenance of Quality Systems for Development and External Quality
- Responsible for the monitoring of compliance with the requirement of GMP for internal and external stakeholders
- Authority to approve or reject, as seen fit, drug product and finished goods product
- Authority to approve or reject written procedures, master batch records, specifications, change controls, validation documentation and vendor document to support internal Alkermes requirements and external CMO requirements
- Authority to review and approve deviations and high-level investigation reports (internal to Alkermes and in support of CMO investigations)
- Responsible for the evaluation of batch manufacturing and control records
- Support and/or lead small teams in the execution of complex, non-routine work assignments for project and/or continuous improvement initiatives.
QUALIFICATIONS:
- Must have a valid US Driver's License
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Experience in API manufacturing, packaging, aseptic processing and powder filling operations desired.
- Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
- Ability to increase others knowledge of US and European GMP regulations.
- Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
- Experience in participating in pharmaceutical technology transfer teams.
- Experience in the qualification of facilities, utilities, equipment and processes.
- Has a thorough understanding of the technology, processes, people and equipment of the plant site.
- Has a thorough understanding of the regulatory process from GLP through commercial manufacturing.
PERSONAL ATTRIBUTES:
- Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
- Ability to utilize knowledge and interpersonal skills to provide leadership, direction, and development of others.
- Strong written and oral communication skills.
- Teacher level knowledge of GMP's.
EDUCATION AND EXPERIENCE:
- Requires a Bachelor’s degree in a scientific discipline or equivalent
- Minimum of 8 years’ experience in a Quality Assurance role in the pharmaceutical industry
The annual base salary for this position ranges from $128,000 to $141,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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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
- Valid US Driver's License
- Bachelor's degree in a scientific discipline or equivalent
- Minimum of 8 years' experience in a Quality Assurance role in the pharmaceutical industry
- Experience in Pharmaceutical Quality Assurance with ability to identify and resolve compliance issues
- Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines
- Teacher-level knowledge of GMPs and ability to increase others' GMP knowledge
- Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control
- Experience participating in pharmaceutical technology transfer teams
- Experience in qualification of facilities, utilities, equipment and processes
- Thorough understanding of plant technology, processes, people and equipment
- Thorough understanding of the regulatory process from GLP through commercial manufacturing
- Experience in API manufacturing, packaging, aseptic processing and powder filling operations
- Strong written and oral communication skills
- Ability to lead, provide direction, and develop others; ability to support/lead small teams on complex projects
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
