Job description

Quality Management Specialist

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

QUALITY MANAGEMENT SYSTEM (QMS)SPECIALIST 

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

The Quality Management System Specialist is responsible for the effective and complaint operation of the Quality Management System (QMS) at Immunocore to ensure alignment with QMS standards, GxP requirements, and company objectives, as applicable. 

The QMS Specialist will support changes, enhancements and upgrades to the eQMS and maintain the validated status of the system and will provide systems expertise in support of maintaining compliance to GxP, regulatory standards and company policies and procedures. The role will also provide support to regulatory health authority inspections and/or audits by external parties, implement training plans to support end users and new starters alike in usage of the QMS and provide data/reports in support of measurement against the company quality objectives and plans.

The ideal candidate will leverage his/her experience, have a strong grasp of the need and philosophy of an effective QMS, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GxP, and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.

Responsibilities:

  • Primary point of contact and has overall responsibility as System Owner for the electronic Quality Management System (eQMS).
  • Working closely with the IT functions, maintains the validated status of the eQMS, ensuring appropriate actions for planned changes, system upgrades, enhancements and configuration changes.
  • Provides expertise in eQMS systems functionality and capability.
  • Provides eQMS support to the organisation during any regulatory health authority inspection and/or audit by an external party.
  • Develops and implements training strategies and plans for eQMS users across Immunocore and for external users, including onboarding of new starters.
  • Develops and maintains SOPs and supporting documentation in support of management of the eQMS as required.
  • Supports compliance through the timely provision of quality data and metrics reporting against company quality objectives and plans.
  • Participates in periodic QMS Review, engaging stakeholders for QMS improvement / enhancement initiatives and supports continuous improvement.
  • Manage, maintain, administer, and support the general upkeep of the QMS.
  • Maintaining an up to date knowledge and log of applicable legislation and regulatory guidelines. Understand and interpret the regulatory expectations and provide guidance on their implementation.
  • At the direction of Line Manager, support Due Diligence and ad hoc requests, as needed.
  • Contribution to all aspects of the quality management of the company’s activities in order to grow its value and maintain compliance to GxP, regulatory standards and company policies and procedures.

The job holder is involved in Wholesale Distribution Activities and therefore must be trained and understand the requirements of Good Distribution Practices as defined in Directive 2001/83/EC and various national legislations (e.g., Rules and Guidance for Pharmaceutical Distributors aka The Green Guide). Training will also include specific aspects of product identification and avoidance of falsified medicines entering the supply chain.

The job holder must have regular and continual training relevant to the role of Quality Management System Owner / Manager / Snr Specialist.

Qualifications: 

Essential

  • Excellent understanding of quality management systems (QMS).
  • Experience with at least one eQMS (e.g., MasterControl, Veeva, TrackWise).
  • Experience utilizing metrics, KPIs, and QTLs to assess risks to QMS and QA processes.
  • Knowledge of Good Documentation Practices (GDP), leading to compliance with regulatory requirements.
  • Work collaboratively with cross-functional teams.
  • Able to foster support and influence stakeholders throughout the company.
  • Worked within Quality Assurance in a similar industry for at least 3 years.
  • Excellent proven written and oral communication skills.
  • Experience with Microsoft Office at an intermediate level (i.e., Word, Excel, PowerPoint Outlook).
  • Previous experience working in clinical research, biotechnology, or pharmaceutical industry.
  • At least 3 years’ experience, or BSc with at least 2 years’ experience with QMS within pharmaceutical and/or biotech industry.

Preferred Experience & knowledge

  • Experience with GxPs (GCP, GMP and GLP an advantage).
  • Working familiarity with two or more eQMS systems (e.g., MasterControl, Veeva, TrackWise).
  • Knowledge of computer systems validation (CSV) in the Pharmaceutical or Biotech industry.
  • Knowledge of the Industry/Clinical trial process and drug development.

Lead with Science and Discover What is Within:

  • We Value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Private medical and dental benefits.
  • 25 days Annual Leave and Bank Holidays
  • 4x Salary Life Insurance
  • 5% Pension Match
  • Income Protection
  • Parental Leave

 

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