Manager of Quality Management Systems

3 weeks ago


Egham, Surrey, United Kingdom Essential Pharma Full time

Essential Pharma is seeking a Quality Systems Manager to spearhead the global enhancement of quality assurance processes, implement a comprehensive 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 collaborative environment and engagement among all departments to cultivate a unified team spirit.
  • Implement the new Quality Management System (QMS) for Essential Pharma, maintaining oversight of quality system processes, ensuring readiness for audits.
  • Work closely with the QA team to manage processes related to quality assurance documentation, including GMP, GDP, GCP/GVP, deviations, complaints, CAPAs, and change controls.
  • Manage reporting against key performance indicators (KPIs) and lead the administration of the Electronic Document Management System (EDMS) once operational, 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 medicines across ten therapeutic areas, focusing on central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products 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

  • In-depth knowledge of Quality Management Systems (QMS), preferably Veeva or similar, acquired through project-based or managerial roles where you have played a key role in implementing new systems and managing change in quality processes.
  • Experience in GxP environments within the pharmaceutical industry, 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 from the office a few days a week based on business needs.
  • Reimbursement of up to £150 for home office expenses.
  • Comprehensive healthcare insurance.
  • Pension scheme with employee contributions of 5% and employer contributions of 3%.
  • Life insurance providing a tax-free death benefit of four times the basic salary.
  • Enhanced family leave and sick pay policies.
  • Annual leave entitlement of 26 days plus bank holidays, with additional time off during the holiday season.
  • Discretionary annual performance bonuses and a recognition program.

Work Environment

We embrace a flexible working culture, allowing individuals to express their authentic selves at work. Our inclusive environment values every voice and promotes autonomy and responsibility among team members. We prioritize relationship-building through engaging activities and regular interactions with leadership, fostering a dynamic and collaborative workplace.

From the outset, we encourage candidates to inquire about our organization, recognizing the importance of mutual fit in the hiring process.



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