Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 4 days ago

Director, Clinical Quality Assurance

eisai61 open roles

Pay
$195,000 – $256,000 a year
Where
New Jersey Nutley
Work mode
Hybrid
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowDirector, Clinical Quality Assuranceeisai · New Jersey Nutley

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on eisai's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. eisai postings stay open a median of 13 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: posted 4 days ago

eisai median: 13 days open

The posting

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 Profile Summary

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

· Oversee and guide conduct 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

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

· Potential for direct people management.

Requirements

· Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research or operations or related area. Prior experience in site monitoring and study management is preferred.

· Strong knowledge of multiple therapeutic areas, eg. neuroscience and oncology, and ability to translate key protocol objectives into auditable activities

· 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 effectively influence and collaborate with senior stakeholders, maintaining Quality's independence and authority in challenging and high-pressure situations.

· 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

· Knowledge of GxP systems including computer system validation and associated regulations, recommended.

· Ability to Travel (approximately 15%)

Candidates near Eisai’s NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.

Eisai Salary Transparency Language:

The annual base salary range for the Director, Clinical Quality Assurance is from :$195,000-$256,000. Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.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://careers.eisai.com/us/en/compensation-and-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.

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:

Right To Work

E-Verify Participation

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against eisai's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on eisai's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    eisai's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.