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

Open nowPosted yesterday

Sr. Manager Quality Assurance

freseniusglobal179 open roles

Where
Wilson, NC
Get the CV for this job

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

Your applicationOpen nowSr. Manager Quality Assurancefreseniusglobal · Wilson, NC

  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 freseniusglobal'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.

12.8% of postings close within 7 days. Measured by our own scanner across the market. freseniusglobal postings stay open a median of 12 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.8%7 days
  4. 20.6%14 days
  5. 35.6%30 days
  6. 58.4%60 days
This job: posted yesterday

freseniusglobal median: 12 days open

The posting

Job Summary

Responsible for administration of Laboratory Quality Assurance (LQA), Compliance, QA Document Control, and QA Critical Systems to assure timely delivery of results to manage the company objectives and Quality Assurance activities related to the implementation and release of Biosimilar Drug Products. Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Administers programs for product stability, annual product reviews, participates in regulatory inspections of the Wilson facility. Assumes responsibility for major projects or contract manufacturing as assigned by the Director, Plant Quality Assurance.

Interacts regularly with Regulatory Affairs, Sales, Corporate Quality Assurance, and Fresenius Kabi Swiss Biosimilars (FKSBS) functions. Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA.

This position manages direct reports in respective quality assurance functions in support of Biosimilars.

Salary Range: $119,000 - $166,000 •Position is eligible to participate in a bonus plan with a target of 14% of the base salary •Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. •Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

  • Responsible for the establishment and administration of Quality Assurance processes for the Wilson facility supporting the implementation and release of Biosimilar Drug Products at the plant manufacturing site. Administers, reviews, and approves standard operating procedures, validation documentation, and manufacturing discrepancy reports related to Biosimilars. Provides cGMP guidance to all departments engaged in the implementation and release of Biosimilar drug products.
  • Assumes responsibilities for the daily functional activities and has authority to make decisions for the Wilson QA department in internal and external meetings. Assumes responsibilities for major projects, such as contract manufacturing, new products, or facility renovations, as assigned by the Director of Plant QA. Actively participates in and supports Continuous Improvement, and Product Transfer Teams.
  • Manages the administration of the Quality system in the Quality Organization. Develops personnel, administers budget, and plans for future resource needs with regard to personnel, equipment, and facility.
  • Directs investigations of product complaints for Biosimilar products and completion of appropriate documentation. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interacts with the Medical Information Department as needed.
  • Coordinates the preparation, review, and approval of the Annual Product Quality Reports.
  • Participates in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
  • Develops human resources to better accomplish and perform in their duties as professional quality managers, supervisors, and technicians.

Additionally:

  • Collaborates with the Environmental Management System Representative for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
  • Collaborates with the Energy Management System Representative for ensuring that Energy Management Requirements are met under ISO 50001 standards.
  • Collaborates with the Occupational Health and Safety Management Representative for ensuring compliance to Occupational Health and Safety is met under ISO 45001.
  • The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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 freseniusglobal'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 freseniusglobal'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

    freseniusglobal'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.