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

Open nowPosted 51 days ago

Senior Manager, Validation

ProKidney15 open roles

Where
Winston-Salem, North Carolina, United States
Get the CV for this job

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

Your applicationOpen nowSenior Manager, ValidationProKidney · Winston-Salem, North Carolina, United States

  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 ProKidney'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.

11.5% of postings close within 7 days. Measured by our own scanner across the market. ProKidney postings stay open a median of 35 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: posted 51 days ago

ProKidney median: 35 days open

The posting

Position Summary

The Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation — including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs — in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.

Responsibilities

  • Provide leadership and direction to Validation team members, driving performance and value creation aligned with site operational and strategic goals
  • Ensure adequate resourcing (capacity and capability) to accomplish site objectives; identify and recommend solutions to alleviate constraints in partnership with the Director of Validation
  • Regularly interacts with cross-functional department leaders on multi-department projects and challenges; supports change initiatives led by senior leadership
  • Actively contribute to and continuously improve the culture of the Validation team and the broader site
  • Supports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA, etc.) under the direction of the Director of Validation
  • Identify areas to improve project delivery efficiency and reduce operational costs; bring forward recommendations and support implementation of approved investment strategies
  • Hands-on troubleshooting and problem solving at the Gemba in support of Validation team members and operations
  • Develop and lead small to medium-sized continuous improvement projects; remain actively involved in projects led by staff members
  • Effectively delegate work and build confidence and competence within direct reports through coaching and mentorship
  • Drive engagement in the technical and personal development of Validation team members
  • Develop strong cross-functional relationships with partners (QA, Manufacturing, Engineering, etc.) and model collaborative behaviors for all team members
  • Provide effective cross-functional leadership to support delivery of site objectives in alignment with the site validation strategy

Qualifications

  • Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering
  • A minimum of 7 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role
  • Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
  • Strong understanding of Validation Lifecycle (GAMP 5) principles
  • Experience with calibration and maintenance management software
  • Knowledge of electronic document management systems
  • Experience with data integrity practices and compliance
  • Strong technical writing skills for qualification documents, SOPs, and work instructions
  • Ability to manage multiple projects simultaneously with minimal supervision
  • Detail-oriented with excellent verbal and written communication abilities
  • Ability to adapt to changing priorities in a deadline-oriented environment
  • Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
  • Knowledge of pharmaceutical equipment, such as centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
  • Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
  • Experience in writing computer system test scripts, validation protocols and summary reports

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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 ProKidney'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 ProKidney'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

    ProKidney'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.