CNX Therapeutics
Website:
cnx-therapeutics.com
Job details:
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 Assurance to support GMP compliance, supplier assurance and Marketing Authorisation Holder (MAH) oversight across our business.
This is a hands-on, coordination-focused role at the heart of our Pharmaceutical Quality System. You will work closely with the Quality Assurance GMP Manager, colleagues across the company and our external partners, helping to keep our products and suppliers managed in line with company procedures, regulatory requirements and quality objectives.
You'll play a real part in inspection readiness and continuous improvement, and you'll get broad exposure to supplier audits, product quality reviews, stability programmes, product launches and technology transfers.
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 GMP compliance and MAH oversight activities, so that products and suppliers are managed in line with our procedures and regulatory requirements
- Coordinating supplier assurance, including audit scheduling and administration, tracking audit commitments and following up observations, actions and CAPAs
- Supporting supplier onboarding, qualification and lifecycle management, making sure the right quality documentation and approvals are in place
- Supporting the establishment, maintenance and periodic review of Quality Technical Agreements, and tracking related actions to completion
- Coordinating Product Quality Review activities across the portfolio, maintaining schedules, tracking deliverables and following up actions and recommendations
- Supporting oversight of Stability Programmes by maintaining tracking tools, monitoring study commitments and coordinating data collection and review
- Coordinating, reviewing and maintaining validation documentation, master manufacturing documentation, pharmacopoeial compliance assessments and other product quality records
- Supporting the management of GMP quality events, investigations, change controls and supplier-related quality issues, keeping them progressing and closed within agreed timelines
- Maintaining schedules, trackers, metrics and performance data to support management review, compliance monitoring and continuous improvement
- Supporting improvement initiatives, product launches, technology transfers, acquisitions and cross-functional projects
Essential
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 assurance
- Experience working in a GMP-regulated environment, ideally in quality assurance or a closely related function
- A working knowledge of Supplier Assurance and GMP
- Excellent attention to detail, with confidence building and maintaining trackers, schedules and metrics (good Excel skills)
- Clear written and verbal communication, and the confidence to follow up actions with suppliers and colleagues
Desirable
- Exposure to Quality Technical Agreements, Product Quality Reviews and stability programmes
- Knowledge of EU/UK GMP guidance, ICH quality guidelines and pharmacopoeial standards
- Experience with an electronic quality management system
- Audit training, or experience supporting audits
You'll also bring
- A methodical approach to problem solving: you gather information carefully, spot risks and help put effective corrective and preventive actions in place
- Strong planning and organisation: you juggle multiple priorities and deadlines, follow up proactively and make sure commitments are delivered on time
- A collaborative style: you build good working relationships with suppliers, contract service providers and colleagues, and you help promote a culture of quality and continuous improvement
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.
Click on Apply to know more.
