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Head of Quality Systems

3 months ago

Egham, Surrey, United Kingdom Essential Pharma Full time

Overview

Essential Pharma is seeking a Quality Systems Manager to spearhead the global integration of quality assurance processes, implement a new quality management system, and foster collaboration across teams in various locations to cultivate a unified approach.

Key Responsibilities

  • Guide a dedicated team, reporting to the Head of QA, promoting a collaborative environment and engaging all teams to ensure a cohesive mindset.
  • Oversee the establishment of the new Quality Management System (QMS) for Essential, ensuring all quality systems processes are maintained and audit-ready.
  • Work closely with the QA team to manage documentation processes related to quality assurance (GMP, GDP, GCP/GVP), including deviations, complaints, CAPAs, and change controls.
  • Take ownership of KPI reporting 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 differentiated, niche medicines for small patient populations. Our extensive portfolio includes over 300 products across ten therapeutic areas, with a focus on central nervous system (CNS) disorders, gastroenterology, ophthalmology, and rare diseases. Our offerings serve patients 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 advancement for Essential Pharma, adding a second product for rare disease treatment and our first development-stage asset.

Qualifications

  • Proven experience with Quality Management Systems (QMS) such as Veeva, gained through project-based or managerial roles involving system implementation and change management in quality processes.
  • Strong knowledge of GxP regulations acquired 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, with the requirement to work two days a week from the office.
  • Financial support for home office setup.
  • Comprehensive healthcare coverage.
  • Pension scheme with employer contributions.
  • Life insurance providing a lump sum benefit.
  • Enhanced family leave and sick pay policies.
  • Generous annual leave package, including additional days off during holiday periods.
  • Performance-based bonuses and recognition programs.

Work Environment

We embrace a flexible working culture that allows individuals to express their authentic selves. Our values foster an inclusive environment where every voice is respected. We prioritize autonomy and responsibility while encouraging social interactions through various team-building activities. Our commitment to employee development is evident in our personalized growth plans, ensuring that everyone has the opportunity to thrive.

We encourage candidates to engage with us during the interview process, as we believe in mutual fit and understanding.