Skip to content

Open nowPosted 12 hours ago

Senior Quality Manager - Systems & Compliance

meiragtx10 open roles

Where
London
Get the CV for this job

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

Your applicationOpen nowSenior Quality Manager - Systems & Compliancemeiragtx · London
  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 meiragtx'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.

12.7% of postings close within 7 days. Measured by our own scanner across the market. meiragtx postings stay open a median of 23 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 12 hours ago

meiragtx median: 23 days open

The posting

Your mission

Responsible for the maintenance and continuous improvement of the GxP Quality Systems at MeiraGTx to ensure they remain complaint and inspection ready at all times. Providing ongoing support and training to the functions across MeiraGTx with regard to Quality Assurance. Ensure MeiraGTx remains inspection ready at all times.

  • Actively reviewing and implementing regulatory updates in collaborations with the teams on site.
  • Updating procedures and processes on site in line with the current regulations.
  • Preparing for and managing regulatory and partner audits.

Job Description

Key Job Competencies

  • Extensive knowledge and experience within pharmaceutical Quality Assurance and GxP regulations within an operations environment (manufacturing & testing). This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles.
  • Extensive knowledge and proven track record of implementing Quality Management Systems which are simple, robust and in compliance with applicable cGxP regulations and guidelines.
  • Experience in preparing for, hosting and follow up on regulatory inspections and/or client audits.
  • Flexibility to meet changing needs and priorities of the business with a special focus on achieving timelines and deliverables.
  • Must have a hands-on approach, and experience with facilitating a Quality Culture and building a “Quality Mindset”.List key competencies to fulfil role.

Job Responsibilities

  • Line management of the QA System & Compliance team as defined in the org chart.
  • Ensure a positive outcome for any regulatory inspections & client audits.
  • Manage the team’s workload in order to ensure the team meets timelines and deliverables as defined by the business. Define priorities and escalate any issues that could impact those to line management.
  • Promote a culture of collaboration and Quality coaching of other areas of the business.
  • Ensure the training needs for the team are met at all times in order to enable team members to be able to achieve their goals and objectives.

Job Background

  • Science based degree e.g. BSc or MSc.
  • Substantial Quality Assurance experience 10 years’ and knowledge of GxP Operations and Quality Systems required for a sterile manufacturing facility applying and understanding of the principles of sterile manufacturing.
  • Strong working knowledge of the principles and guidelines for GxP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations.
  • Demonstrated ability to make sound decisions regarding evaluation of GxP compliance, and leadership abilities in the management of QA oversight.
  • Is not afraid to make decisions for the group. Holds self and others accountable in achieving goals.
  • 8-10 years experience in line management with a proven track record of developing and leading a high-performance team.
  • Strong leadership skills with good collaboration, communication and problem-solving skills.
  • Strong interpersonal skills, must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders.
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 meiragtx'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 meiragtx'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

    meiragtx'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.

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.