At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary
This position is responsible for maintaining and improving Quality Systems at Eisai Exton to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, validation support, training, event management (deviations, complaints, CAPA), and change control (global and local). This position has responsibility for maintaining and improving electronic systems to support the same. The role may interface with Quality System personnel in other Eisai sites.
The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.
Essential Functions
Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
Contribute to quality risk management, and strategies that support quality business objectives and building an effective quality culture.
Support regulatory (e.g., FDA) and customer audits at the Exton site. Contribute to regulatory audit responses to ensure response is consistent with Eisai local and corporate policy.
Contribute to the internal and external audit programs, including self-inspections.
Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for Exton Site including OOS, Deviation, Product Complaints, and CAPA on time completion.
Contribute and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.
Requirements
Education and Experience
Bachelor’s degree, preferably in science related discipline or IT related field.
5 – 7 years of experience working with Quality Systems (auditing, change control, CAPA, deviations, etc.) and quality risk management.
Understanding and application of GMP’s (EU, JP, US) including relevant laws, guidance, directives and industry practices.
Demonstrated experience in working with Quality Systems IT applications.
Trained within a regulated Pharmaceutical/biotech/medical device environment.
Physical requirements include the ability to work in a typical office environment.
Technical
Strong attention to detail as demonstrated through consistent quality of work.
Excellent written and verbal communication skills.
Computer proficiency in MS Word and Excel required; previous experience in TrackWise preferred.
Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output.
Ability to anticipate potential problems and take proactive action to avoid/minimize impact
Anticipates consequences of actions and how they impact other areas.
Ability to independently prioritize, plan, and schedule work.
Timely follow up to ensure satisfactory resolution to issues.
Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.
Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
# LI – SC1
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
