Associate Director, Clinical QA Audit (Remote Opportunity)
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisais areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&;D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The companys areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Companys greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
The Associate Director, Clinical Quality Assurance oversees GCP activities at Eisai, our Investigator Sites and CROs , leads GCP audits and inspection readiness. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization of clinical trials. This person will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams. This is a high visibility position with great impact potential.
Proactively provide GCP QA support for clinical development activities to protect patient safety & well being, maintain data integrity, and support operational excellence
Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits
Author and manage Audit Plans and Audit reports
Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
Manage health authority inspection preparation activities and provide leadership and oversight during inspections
Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
Compile and analyze audit metrics to communicate trends to business groups
Conduct GCP training sessions for business groups
Manage direct reports (if applicable)
Bachelors degree in associated functional discipline, advanced degree preferred
Minimum of 3-6 years of Clinical Quality Assurance auditing. Preferably 8+ years experience in Clinical research/operations/data management or related area
Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
Experience of inspection management
Experience with supervising direct reports preferred
Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
Strong analytical skills and report writing skills
Ability to demonstrate tact as a representative of the CQA Department
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
Ability to Travel minimum of 30%
Flexible job location, remote or onsite
Must be willing and able to be onsite at Eisai's offices for employee orientation, meetings, and as otherwise required
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisais policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer - Minority / Female / Disability / Vet
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