Manager, Quality Assurance

Alkermes; Wilmington (DE); On-site; USD 120,000 - 170,000; Full time

Job summary

Alkermes in Wilmington, Delaware, is seeking an experienced QA leader to manage day-to-day quality operations across QA and adjacent areas. You will develop and implement tactical initiatives directed by senior management and communicate events to Management when thresholds are outside the area of responsibility.

The role requires a Bachelor's degree in a scientific discipline and at least 8 years in pharmaceutical QA, preferably with parenteral dosage forms.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• Minimum of 8 years’ experience in a Quality Assurance role in the pharmaceutical industry, preferably with parenteral dosage forms.

Responsibilities

• Approve or reject master production records and SOPs.
• Approve or reject intermediate, bulk and finished products as seen fit.
• Participates in management processes for quality and compliance.
• Ensure that all necessary testing is carried out.
• Ensure initial and continuing training of direct reports is carried out and adapted as needed.
• Monitor investigations and factors impacting product quality.

Skills

GMP Knowledge

Quality Systems

GMP Compliance

Technology Transfer

Facilities Qualification

Regulatory Knowledge

Communication Skills

Site Knowledge

Regulatory Process Understanding

Education

Bachelor’s degree in scientific discipline

Job description

This function is responsible for managing workflow within and outside Quality Assurance. This function resolves and supports day to day events between direct reports and other areas within the Quality Assurance organization. This function also resolves and supports day to day events between Quality Assurance, other quality units and areas outside of quality. This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside of the area of responsibility.

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.

Skills/Abilities:

• Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
• Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
• Experience in participating in pharmaceutical technology transfer teams.
• Experience in the qualification of facilities, utilities, equipment and processes.
• Ability to increase others knowledge of US end European GMP regulations and guidance.
• Strong written and oral communication skills.
• 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
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development cross-functionally.

Education/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, preferably with parenteral dosage forms.

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• Authority to approve or reject written standards, including Master Production Records, Standard Operating Procedures, Specifications, Sampling Instructions and Test Methods.
• Authority to approve or reject, as seen fit, intermediate, bulk and finished products.
• Participates as appropriate in management processes for quality and compliance.
• Responsible for ensuring that all necessary testing is carried out.
• Responsible for ensuring that the required initial and continuing training of direct reports is carried out and adapted according to need.
• Responsible for investigations and monitoring of factors which may affect product quality.
• Responsible for the evaluation of batch manufacturing and control records.
• Responsible for the evaluation of written standards.
• Responsible for the monitoring of compliance with the requirement of GMP.
• Responsible for the supervision of direct reports.