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Quality Systems Operations Manager
3 months ago
Essential Pharma is seeking a Quality Systems Manager to spearhead the globalization of quality assurance processes, implement and integrate a new quality management system, and foster collaboration across teams in various locations to promote a unified approach.
Key Responsibilities
- Oversee a dedicated team, reporting to the Head of QA, ensuring a cooperative environment and engaging all teams to cultivate a unified mindset.
- Implement the new Quality Management System (QMS) for Essential, maintaining oversight of quality systems processes and ensuring readiness for audits.
- Work closely with the QA team to manage documentation processes related to quality assurance (GMP, GDP, GCP/GVP), handling deviations, complaints, CAPAs, and change controls.
- Take ownership of reporting against key performance indicators (KPIs) and lead the administration of the Electronic Document Management System (EDMS) database, including user training and configuration.
About Us
Essential Pharma is an international specialty pharmaceutical organization committed to ensuring access to clinically distinct, niche medications for small patient populations. Our extensive portfolio includes over 300 products across ten therapeutic areas, focusing on central nervous system (CNS) disorders, gastroenterology, ophthalmology, and rare diseases. Our treatments are available in more than 70 countries.
We proactively identify low-volume, challenging-to-manufacture therapeutic products and late-stage clinical development assets targeting rare diseases. Our recent acquisition of Renaissance Pharmaceuticals marks a significant achievement for Essential Pharma, adding a second product for rare disease treatment and the first development-stage asset to our portfolio.
Qualifications
- Expertise in Quality Management Systems (QMS), such as Veeva or similar, acquired through project-based or managerial roles where you have contributed to the implementation of new systems and led change management in quality processes.
- Knowledge of Good Practice (GxP) standards gained from experience in a pharmaceutical environment, with familiarity with US and EEA regulations.
- Eligibility to reside and work in the UK.
Benefits
- Competitive salary starting from £65,000.
- Flexible working arrangements, allowing you to balance office attendance based on business needs and role requirements.
- Financial support for home office setup.
- Comprehensive healthcare coverage.
- Pension plan with contributions from both employee and employer.
- Life insurance coverage providing a lump sum benefit.
- Enhanced family leave and sick pay policies.
- Generous annual leave policy, including additional time off during holiday periods.
- Performance-based bonus opportunities.
- Employee recognition programs.
Our Culture
We embrace a culture of agile working, allowing individuals to express their authentic selves. Our values promote inclusivity, where every voice is heard and respected. We believe in treating each other with trust and responsibility, fostering a collaborative environment through engaging activities and events. Our commitment to employee development is evident in our personalized growth plans, ensuring that everyone has the opportunity to thrive.
From the outset, we encourage candidates to engage with us, as we value the importance of mutual fit in the hiring process.
