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

Open nowPosted 16 days ago

Director, QA Validation

kindeva79 open roles

Where
Maryland Heights, MO, USA
Get the CV for this job

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

Your applicationOpen nowDirector, QA Validationkindeva · Maryland Heights, MO, USA

  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 kindeva'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.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 16 days ago

The posting

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.  The Impact You Will Make We are seeking a seasoned Quality Assurance Validation Subject Matter Expert (SME) to lead the QA validation function at our sterile injectable GMP manufacturing site. The successful candidate will provide expert guidance and oversight for all aspects of equipment and utility qualification, process and cleaning validation, media fill activities, process validation, computer system validation, and data integrity compliance. This individual will play a key leadership role in ensuring that validation activities meet regulatory expectations, align with internal quality standards, and support efficient, compliant operations.  Key Responsibilities

Serve as the QA functional lead for validation, owning the quality oversight of validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems. Review and approve validation master plans, protocols, reports, and risk assessments to ensure compliance with current GMP regulations, guidance documents, and internal procedures. Provide QA oversight for media fill validations, ensuring proper design, execution, and documentation aligned with sterile product manufacturing requirements.  Lead the QA review and approval of cleaning validation strategies including campaign rationale, worst-case scenarios, acceptance criteria, and continued verification.  Provide QA guidance during qualification of equipment and utilities (URS, DQ, IQ, OQ, PQ), ensuring appropriate risk-based approach and adherence to applicable standards.  Oversee QA review and approval of computer system validation (CSV) deliverables in accordance with 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.  Serve as QA approver and reviewer for periodic reviews and requalification strategies across validation lifecycle elements.  Champion data integrity across validation documentation, ensuring ALCOA+ principles are followed and integrated into all validation activities.  Collaborate with cross-functional teams (Engineering, Validation, Manufacturing, IT, QC) to support timely project execution while upholding QA expectations.  Act as the SME during internal and external inspections (FDA, EMA, customer audits), defending the site's validation and QA oversight practices.  Identify and implement continuous improvement opportunities in the validation quality system and associated documentation lifecycle. Mentor and train QA and validation staff on current validation expectations and regulatory updates.

Qualifications

Bachelor’s or advanced degree in life sciences, engineering, or a related field.  Minimum 8 years of experience in GMP pharmaceutical manufacturing, with strong experience in quality assurance oversight of validation programs.  Deep understanding of regulatory requirements (21 CFR Parts 210, 211, 11; EU GMP; Annex 1; ICH Q8–Q10; WHO, PIC/S) and industry best practices (GAMP 5).  Demonstrated expertise in sterile manufacturing validation, particularly aseptic process simulation (media fill), cleaning validation, and facility qualification.  Hands-on experience with computer system validation and data integrity controls in a GMP environment.  Proven ability to collaborate effectively in a matrixed environment and influence cross-functional teams.  Excellent communication, documentation, and problem-solving skills.  Prior experience representing QA validation during regulatory inspections strongly preferred. 

Disclaimer This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required. Role Holder may be asked to perform other duties as required #LI-Onsite #JJ

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 kindeva'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 kindeva'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

    kindeva'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.