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Senior QA Specialist, GCP/GLP

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive salary
Start date
11 Jun 2021
Closing date
11 Jul 2021

View more

Discipline
Quality, Auditor, GCP, GLP, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

We are currently recruiting for a Senior QA GCP/GLP Specialist to join us to provide additional knowledge and capability to the QA Team.

Your responsibilities in this role would be:

  • Participate in the development, implementation, and maintenance of the company’s GCP & GLP quality management system and facilitate continuous improvement.
  • Provide GCP and GLP QA oversight and support to internal staff and represent QA on GCP & GLP Related project teams.
  • Develop and implement annual audit strategies, and quarterly GCP & GLP audit schedules.
  • Schedule, oversee and perform (either directly or via external auditors) routine and non-routine quality assurance audits to include, but not limited to: clinical investigator sites, animal testing sites, vendors, process, and system.
  • Assist in the selection of external auditors, coordinate audits, and associated documentation in a timely manner.
  • Support internal and external GLP testing to ensure compliance with guidelines, SOPs, protocols, and industry standards.
  • Conduct QA review of GLP methods, data and reports.
  • Assure/coordinate proper and complete resolution of findings/non-compliant situations in a timely manner, including approval of corrective action/preventive action (CAPA) plans, as necessary.
  • Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
  • Participate in the preparation and conduct of inspections and audits performed by regulatory authorities and other parties.

To be successful in this role, you will have the following skills and experience:

  • Bachelor’s Degree in a scientific discipline
  • A strong working knowledge of GCP, GLP and ICH requirements
  • Previous experience within Advance Therapeutic Medicinal Products (ATMPs)
  • Proven experience in the Pharmaceutical industry within QA
  • Strong verbal and written communication skills
  • Excellent organization and multi-tasking skills
  • Ability to think strategically in order to improve current processes
  • Ability to work independently and prioritise with minimal supervision
  • Ability to work effectively across a matrix organisation

Do you want to feel inspired every day?  We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

Collaborate. Contribute. Change lives

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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