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Quality Systems Officer

Employer
Oxford BioMedica (UK) Limited
Location
Oxford, Oxfordshire (GB)
Salary
Competitive
Start date
16 Mar 2019
Closing date
29 Mar 2019

View more

Discipline
Quality, GMP, QA / QC, Systems Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.

Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.

Our recent successes are driving significant growth. As such, we are looking to recruit a Quality Systems Officer to join our QA team.

Job purpose:

  • Design and provide continuous improvement of Quality Management Systems.
  • Monitor and produce metrics of GMP compliance with current Quality Management Systems.
  • Support all aspects of supplier qualification and ongoing risk management.
  • Provide primary Quality support for all new products, projects and suppliers/service providers.
  • Carry out internal audits and follow up to promote continuous improvement.
  • Perform Annual Product Quality Reviews.
  • Hosting of client and regulatory audits and inspections.
  • Support and co-ordinate responses to client and regulatory audits and inspections.

Key responsibilities and accountabilities:

  • Supports the quality of GMP manufacturing practices (i.e. aseptic practices) and or analytics during manufacturing/ testing of drug/vector substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-specific authorisations.
  • Providing direct quality team support during customer and regulatory audits.
  • Create and maintain a state of readiness in order to satisfy regulatory and client expectations during audits and inspections 
  • Work in a team in order to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
  • In depth knowledge of the pharmaceutical industry in terms of regulations and compliance.
  • Awareness and understanding of Quality Systems in order to support them effectively.
  • Communicate compliance updates.
  • Knowledge of the different aspects of the OXB business in order to assist in investigations.
  • Actively support continuous improvement of Quality Management Systems
  • Represent Quality in all new projects to ensure quality is built in as early as possible.
  • Supporting Quality based projects working as part of a multidisciplinary team as required.
  • Promoting continuous improvement of the Quality Management System
  • Ensure that the manufacturing and or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
  • Ensuring and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.
  • Reports on-going progress with QA activities and Deviations to Head of Quality.
  • Attend meetings and follow up communications across the Quality Systems team and other departments.

Key skills and requirements: 

  • Good experience working within pharmaceutical QA.
  • Working knowledge of GMP & Quality related pharmaceutical regulations & standards.
  • A level or National Certificate in a Science discipline.
  • Higher National Certificate or Degree in science discipline desirable.
  • Computer literate (Word, Excel, MS Office).
  • Solid working knowledge of Validation and Quality Management systems.

Person Specification: 

  • Experience of conducting quality based audits, investigations and root cause analysis.
  • Understanding and experience of Change Control.
  • Experience of regulatory and or customer /client audits and inspections.
  • Understanding & experience of GMP and pharmaceutical industry QA requirements.
  • Experience in document control or records management systems in a regulated environment.
  • Good interpersonal and communication skills.
  • Excellent attention to detail.
  • Good team player, and must also be able to work alone.
  • Good organisational and time management skills.
  • Able to prioritise workload, decisive thinker able to work within agreed timescales.
  • Experience of use of an electronic Document Management system to GMP standards.

No agencies please

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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