Director, Clinical Quality Assurance

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.

Director, Clinical Quality Assurance

The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).

Essential Functions

* Independently conduct audits

* Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits

* Facilitate Sponsor health authority inspections of global clinical facilities and study sites

* Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs

* Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.

* May be responsible for direct people management including goal setting, performance management, development, and engagement.

Requirements

* Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.

* 5+ years of experience in GCP auditing.

* Substantial experience in inspection management.

* Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.

* Demonstrated ability to operate and influence decision-making processes

* Effective communication skills

* Successful track record of supervising employees and managing cross-cultural differences

* Technical and administrative capabilities to independently carry out routine, complex and for-cause audits

* Knowledge of data integrity controls and systems quality for clinical area

* Strong analytical skills and report writing skills

* Experience with GxP systems including computer system validation and associated regulations, recommended.

* Ability to Travel (approximately 15%)

This role is hybrid and requires at least 2 days per week working onsite in our Nutley, NJ office.

Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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.

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