Executive, Quality Systems

CNX Therapeutics | B Corp™ Certified; Mumbai; À distance; INR 1 200 000 - 2 400 000; Plein temps

Résumé du poste

CNX Therapeutics, a European pharmaceutical company and B Corp, seeks an Executive, Quality Systems to maintain and improve the QMS, ensuring GMP/GDP compliance and inspection readiness. This is a remote role for a candidate based in Mumbai, joining the CNX Quality team.

You will administer the eQMS, manage document control, deviations, CAPA and change control, and support audits, training and supplier quality to uphold data integrity and regulatory standards.

Qualifications

• Degree in a life science subject or equivalent practical pharma quality experience.
• Experience in a GxP-regulated environment and quality systems.
• Knowledge of document control, deviations, CAPA and change control.
• Strong attention to detail and analytical skills.
• Excellent written and verbal communication; stakeholder management.
• Proficient Excel; comfortable with metrics and reports.

Responsabilités

• Maintain and continuously improve the QMS to stay GMP/GDP compliant.
• Administer the electronic Quality Management System (eQMS), including document control and user management.
• Review and coordinate controlled documents (SOPs, policies, work instructions).
• Maintain training matrices and deliver eQMS training.
• Support deviations, CAPAs, change controls and complaint handling.
• Assist root-cause investigations and effectiveness reviews of corrective actions.
• Support internal audits and regulatory inspections preparation.
• Manage incoming Product Quality Complaints and customer quality communications.
• Review batch documentation for completeness and compliance.
• Track quality metrics and KPIs; prepare data for management reviews.
• Uphold GDPR and keep information confidential.

Connaissances

Quality systems

GxP

eQMS

Document control

CAPA

Change control

Deviations

Audits

Data analysis

Excel skills

Stakeholder communication

Formation

Life science degree

Outils

eQMS software

Description du poste

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

• 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. CNX Therapeutics is a rapidly growing European pharmaceutical company dedicated to improving the lives of patients through the supply of essential medicines. We license and distribute a portfolio of medicines for CNS, critical care and other conditions, both directly and through strategic partnerships, in over 60 countries worldwide. A certified B Corp company, our vision is to become a recognised partner of choice through our commercial excellence, patient focus and presence across Europe.