Associate Director, Clinical QA Audit (Remote Opportunity)

招聘企业
Eisai Inc.
工作地点
Woodcliff Lake
薪金
Competitive
已发布
2019年10月21日
关闭
2019年10月27日
工作职责
审计
行业
IT
合同类型
永久
工作时间
全职
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.

Responsibilities

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)

Requirements

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

JOB REQUIREMENTS:

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 from tblHiringOrgDefaults

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