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

Open nowPosted today

Quality Assurance Regulatory Compliance Specialist

pciservices288 open roles

Where
Stamullen Co Meath IRL
Get the CV for this job

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

Your applicationOpen nowQuality Assurance Regulatory Compliance Specialistpciservices · Stamullen Co Meath IRL

  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 pciservices'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.

13.8% of postings close within 7 days. Measured by our own scanner across the market. pciservices postings stay open a median of 21 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.8%7 days
  4. 22.3%14 days
  5. 37.8%30 days
  6. 59.0%60 days
This job: posted today

pciservices median: 21 days open

The posting

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Role

The QA Regulatory Compliance Specialist is responsible for the establishment and ongoing management of third-party and clinical supply chains within PCI’s clinical regulatory compliance function. The role supports right-first-time QP release and works closely with clients and internal stakeholders in the management and oversight of regulatory change across multi-site supply chains.

Main Purpose of Job

The role is responsible for the supply chain establishment and compliance oversight of third-party and clinical products within PCI’s clinical regulatory compliance department, ensuring quality and regulatory requirements are met throughout the product lifecycle.

Main Responsibilities

  • Responsible for the creation and maintenance of the Product Specification File (PSF) for the clinical supply chain where QP certification is performed.
  • Develop and manage the Quality Systems and Compliance frameworks that support the maintenance and release of clinical supply chains at PCI.
  • Maintain the Approved CMO list for the clinical supply chain.
  • Maintain the Supply Chain / CMO Risk Register, identifying at-risk sites that require additional support or remediation.
  • Ensure ongoing compliance with customer, regulatory and internal requirements.
  • Manage and co-ordinate the Supplier Management Programme, including supplier audits, the preparation and review of Quality Technical Agreements, supplier qualification and vendor performance management for third-party suppliers.
  • Prepare and maintain the third-party / clinical approved product and supplier lists.
  • Prepare QP declarations for review and approval by the third-party QP at PCI.
  • Prepare and review Product Quality Reviews (PQRs) in support of third-party QP release.
  • Review and track third-party change controls with a product quality or regulatory impact.
  • Support the management of the Manufacturing and Importation Licence held by the Millmount entity and the associated variations to it.
  • Raise Deviations, Corrective Action Requests and Non-Conformance reports in a timely manner, ensuring issues are communicated to management.
  • Generate SOPs, Forms, Job Aids and Work Instructions within the MasterControl system.
  • Identify and support opportunities to improve processes and procedures.
  • Undertake and manage specific or ad hoc projects as and when required to meet departmental and business needs, within the scope of the role.

Knowledge / Skills & Experience

Essential:

  • Bachelor's degree in a scientific, technical or engineering discipline (or associate degree / diploma / certificate). Relevant experience may be considered in lieu of formal educational requirements.
  • Minimum 5 years’ experience within the pharmaceutical and/or biological industry, including at least 2 years in a regulatory- or compliance-focused role.
  • Strong working knowledge of EU regulatory requirements applicable to pharmaceuticals, with the ability to apply GMP regulations and international guidelines across all aspects of the role.
  • Ability to set clear goals, communicate them effectively and ensure progress to completion against predefined targets.
  • Demonstrated client-facing experience.

Desirable:

  • Experience auditing external suppliers, contractors and vendors.
  • Experience with regulatory filings and variations.

#LI-JP1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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 pciservices'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 pciservices'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

    pciservices'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.