Overview
Senior Manager, Software Validation Quality Professional Jobs in Nutley, New Jersey, USA at Eisai
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.
The Software Developer Validation Quality Professional will work closely with the quality assurance clinical systems lead to deliver on internal validation efforts and audits of Eisai’s vendor systems.
The Senior Manager, Software Validation Quality Professional will work closely with the quality assurance clinical systems lead to deliver on internal validation efforts and audits of Eisai’s vendor systems.
Essential Functions
QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on system validation.
Support computer system audits for review of SDLC and data integrity controls.
Review CAPA and verification of CAPAs of system audits.
Support health authority audits/inspections for inspection readiness.
Requirements
Bachelor’s degree in associated functional disciplines including IT, Data Sciences, and others.
Software development familiarity with both Agile and Waterfall methodology.
Knowledge of coding matrix and complexity measurements/determination.
Minimum 8 years’ experience in pharmaceutical industry or similar.
Familiarity with regulations governing software development and validation.
Knowledge of Statistical Programming is preferred but not required.
Knowledge of GCP/GMP is preferred.
Auditing experience is preferred but not required.
Must have professional communication skills, strong independent time management skills, and the ability to manage multiple projects concurrently.
Ability to travel (approximately 10-20%).
Location:
Hybrid in our Nutley, NJ office
.
Salary and Benefits
The base salary range for the Senior Manager, Software Validation Quality Professional is from $124,600 to $163,500. This position is eligible to participate in the Eisai Inc. Annual Incentive Plan
. Final pay determinations will depend on various factors including experience, education, knowledge, and skills.
Employees are eligible to participate in company employee benefit programs. For more information, visit
Other benefits may be available; please discuss with your recruiter.
Equal Opportunity Employment
Eisai is an equal opportunity employer committed to recruiting, hiring, training, and promoting without regard to race, color, religion, gender, age, national origin, citizenship, marital status, sexual orientation, gender identity, disability, or veteran status. We prohibit discrimination and provide reasonable accommodations as needed.
Eisai participates in E-Verify. For more information, see Right To Work and E-Verify Participation.
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Title: Senior Manager, Software Validation Quality Professional
Company: Eisai
Location: Nutley, New Jersey, USA
Category: Healthcare (Data Scientist, Medical Science), Quality Assurance – QA/QC
