Job description

Quality Management System (QMS) Administrator

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

QUALITY MANAGEMENT SYSTEM (QMS) ADMINISTRATOR- 12 month contract (FTC)

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 (QMS) Administrator supports the management, maintenance, administration and general upkeep of the Quality Management System (QMS).  This role functions to support the QA department as well as cross-functional teams at IMC to ensure alignment with QMS standards, GxP requirements, and company objectives, as applicable.  The QMS Administrator will support the development and maintenance of metrics for audits, Quality Issues (QIs), Complaints, Non-Conformances, Change Control, CAPAs, RCAs, and KPIs.  This role will also assist with QA training to the broader organization and the archival of documents/files, as needed.

The ideal candidate will leverage his/her experience, understanding of 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:

  • To manage, maintain, administer, and support the general upkeep of the QMS.
  • To administer, issue and track documents within the eQMS.
  • Collaborate with stakeholders to develop and manage GxP staff training for new joiners.
  • Manage tracking systems to ensure that the QMS is in a controlled state and is compliant with policies, SOPs, best practices, and requirements for the following, as applicable:
    • Approved Supplier List (ASL).
    • Audits (internal/external).
    • CVs (GxP Consultants/Contractors).
    • QIs, Complaints, Non-Conformances, CAPAs, RCAs, and Change Control.
  • Provide/update information for the management and distribution of QMS metrics.
  • Plan, build, and facilitate QA trainings, as needed.
  • Assist with the archival and long-term storage of GxP documents, files, and related materials.
  • Support with managing laboratory notebook distribution and scanning across the company.
  • Provide backroom QC support during regulatory inspection and external audits.
  • At the direction of Line Manager, support Due Diligence and ad hoc requests, as needed.
  • Support review and issuance of monthly QMS metrics.
  • Attend and contribute to action items identified as part of weekly Quality Monitoring meetings.
  • At the discretion of the Head of QA, support Due Diligence and ad hoc requests, as needed.

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).

Qualifications: 

Essential

  • Excellent understanding of quality management systems (QMS) and standards.
  • 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.
  • Worked within Quality Assurance in a similar industry for at least 2 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.
  • 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).
  • 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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