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

Open nowPosted 15 days ago

GMP Operational Quality Senior Manager

Workable (global search)108,016 open roles

Where
Boston, MA, United States
Get the CV for this job

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

Your applicationOpen nowGMP Operational Quality Senior ManagerWorkable (global search) · Boston, MA, 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 Workable (global search)'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.

7.9% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 7 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 7.9%7 days
  4. 14.9%14 days
  5. 34.0%30 days
This job: posted 15 days ago

Workable (global search) median: 7 days open

The posting

The GMP Operational Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. This role coordinates or executes activities on multiple complex projects with emphasis on QA GMP disposition of drug products and devices.

Responsibilities:

  • Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
  • Participates in cross-functional teams as an experienced Quality technical resource
  • Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
  • Assists Change Control owners with ensuring compliance to change procedure requirements
  • Initiates and assesses change controls
  • Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
  • Ensures appropriate CAPA actions are identified and addressed.
  • Approves investigations/CAPAs.
  • Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP) and finished goods (FG) disposition activities
  • Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems
  • Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
  • Identify and communicate risks and assist with risk mitigation plans as necessary
  • Supports internal audit or external audit programs

Requirements

  • Bachelor's degree in a scientific or allied health field.
  • 8 years of experience.

Must have:

  • In- depth knowledge of both the conceptual and practical application of cGMPs in a biologics + devices pharmaceutical setting; in-depth knowledge of global GMP requirements in support of GMP Drug Product manufacturing
  • Experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines
  • Experience in identifying, assessing and mitigating potential risks utilizing quality risk management best practices
  • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with electronic document management systems (e.g., QDocs, Trackwise, Veeva)

Benefits

1 year contract with possible extension

Administrative shift

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 Workable (global search)'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 Workable (global search)'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

    Workable (global search)'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.