Quality Assurance Manager

4 weeks ago

Egham, Surrey, United Kingdom Essential Pharma Full time

Overview

Essential Pharma is in search of a Quality Assurance Manager with extensive knowledge of Good Manufacturing Practices (GMP). In this role, you will oversee the management of quality assurance functions associated with the outsourced manufacturing processes of Essential Pharma products, ensuring adherence to regulatory standards and upholding exceptional product quality and safety.

Key Responsibilities

  • Reporting to the Associate Director of QA – GMP Operations, you will assist in the upkeep of the Quality Management System (QMS) in alignment with regulatory requirements (e.g., FDA, EMA, ICH).
  • Ensure comprehensive documentation of all QA processes and procedures, ensuring they are adhered to and continuously refined.
  • Conduct both internal and external audits and participate in regulatory inspections.
  • Guarantee that all products meet applicable regulations and guidelines.
  • Stay informed about changes in regulatory requirements and ensure prompt implementation of new regulations.
  • Prepare for and engage in regulatory inspections and audits, including visits to Contract Manufacturing Organizations (CMOs).
  • Manage risk, documentation, and reporting effectively.
  • Collaborate with cross-functional teams, including manufacturing, supply chain, MSAT, R&D, and regulatory affairs, to maintain product quality throughout its lifecycle.
  • Promote continuous improvement, training, and the adoption of best practices within the quality domain across the organization.

Company Overview

Essential Pharma is a global specialty pharmaceutical organization committed to ensuring access to clinically differentiated, niche medications for small patient populations. Our diverse portfolio encompasses over 300 medicines across ten therapeutic areas, with a concentration on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products 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 achievement for Essential Pharma, adding a second product for rare disease treatment and the first development-stage asset to our portfolio.

Qualifications

  • Bachelor's degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related discipline.
  • Demonstrated experience in quality assurance within the pharmaceutical sector, with essential experience in manufacturing operations of medicines; experience with biological products is advantageous.
  • In-depth understanding of Good Manufacturing Practices.
  • Exceptional communication and interpersonal abilities.
  • Capability to manage multiple projects and priorities in a dynamic environment.
  • Certification in quality assurance (e.g., ASQ Certified Quality Manager) is preferred.

Benefits

  • Competitive salary starting from £50,000.
  • Flexible working arrangements based on business needs and role requirements, with a minimum of two days per week in the office.
  • £150 reimbursement for home office expenses.
  • Healthcare insurance coverage.
  • Pension plan with employee contribution of 5% and employer contribution 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 bonus.
  • Recognition program for employee achievements.

Work Environment

We embrace flexible working arrangements, allowing individuals to express their authentic selves at work. Our inclusive culture values every voice and fosters a sense of autonomy and responsibility. We prioritize connection among colleagues through engaging activities and events, ensuring regular access to leadership. Our core values of dynamism, responsibility, trustworthiness, and collaboration guide our interactions and support our commitment to employee growth and personalized development.

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