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CNX Therapeutics

Executive, Quality Systems

Posted 3 days ago
2-5 years experience
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AI Summary

The role involves maintaining and improving the Quality Management System to ensure compliance with GxP, GMP, and GDP regulatory standards. You will manage document control, handle deviations and CAPAs, support audits, and oversee product quality complaints.

Who We Are

At CNX Therapeutics, we’re building a growing European pharmaceutical business with a clear ambition: to improve access to medicines that make a meaningful difference to patients’ lives. With a diverse portfolio and an expanding global footprint, we’re continuing to grow through both our existing business and new opportunities.

Our people are central to this journey. We’re a collaborative, entrepreneurial and fast-moving organisation where individuals have the opportunity to take ownership, make an impact and help shape how we grow. Joining CNX means becoming part of an ambitious team at an exciting stage of our development, with the opportunity to contribute to both our business and the patients we ultimately serve.

The Opportunity


We are looking for an Executive, Quality Systems to help maintain and continuously improve our Quality Management System (QMS), keeping us compliant with GxP requirements, regulatory standards and company procedures.

Working alongside the Manager, Quality Systems, you will be a key point of contact for colleagues, suppliers, external partners and customers, promoting a culture of quality and helping the business stay inspection-ready.

This is a varied, hands-on role that touches almost every part of the quality system, from document control and eQMS administration to deviations, audits, supplier quality and complaints.

This is a remote role for someone based in Mumbai. You will be employed through our employment partner on behalf of CNX Therapeutics, and you will work day to day as part of the CNX Quality team.

What You’ll Be Doing

  • Supporting the maintenance and continuous improvement of our QMS, so that we remain compliant with GMP, GDP and other applicable regulatory requirements

  • Acting as administrator for our electronic Quality Management System (eQMS), covering document control, user administration, record management and archiving

  • Reviewing, formatting and coordinating controlled documents, including SOPs, policies, work instructions and forms

  • Maintaining training matrices, assigning role-based training through the eQMS, and delivering eQMS training to new colleagues

  • Supporting the management of deviations, CAPAs, change controls and complaints, monitoring progress and escalating overdue actions

  • Taking part in root cause investigations and supporting the implementation and effectiveness review of corrective and preventive actions

  • Supporting the internal audit programme, and helping us prepare for regulatory inspections, customer audits and supplier audits, including logistics, documentation and back-room support

  • Managing incoming Product Quality Complaints and customer quality communications, and supporting complaint investigations

  • Carrying out administrative batch documentation reviews to check completeness and compliance

  • Tracking quality metrics and KPIs, analysing trends, and preparing data for Quality Management Review

  • Upholding GDPR requirements and keeping quality, regulatory, customer and supplier information confidential


What We’re Looking For

Essential

  • A degree in a life science subject (such as pharmacy, chemistry, biology or biochemistry), or equivalent practical experience in pharmaceutical quality

  • Experience working in a GxP-regulated environment, ideally in quality assurance or quality systems

  • A working knowledge of quality system processes, including document control, deviations, CAPA and change control

  • Excellent attention to detail, with the ability to spot errors, inconsistencies and compliance risks

  • Strong analytical skills, with confidence using data and evidence to investigate issues and recommend solutions

  • Clear written and verbal communication, and the ability to build productive relationships with internal and external stakeholders

  • Good Excel skills and comfort working with metrics and reports


Desirable

  • Experience administering an electronic quality management system

  • Knowledge of GMP and GDP requirements

  • Exposure to complaint handling, supplier qualification or batch documentation review

  • Internal audit training, or experience supporting audits and inspections

  • Experience delivering training to colleagues

  • Awareness of GDPR and data protection principles


You'll also bring

  • A commitment to quality and compliance: you care about standards and process integrity

  • A proactive approach to improvement: you look for ways to make systems and processes work better

  • A collaborative style: you communicate clearly and help promote a culture of quality across the business


What We Offer


We offer a competitive salary and benefits package in line with local practice and statutory requirements. Full details will be shared during the recruitment process.

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