Skip to main content

This job has expired

Qualified Person

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
28 Apr 2022
Closing date
28 May 2022

View more

Discipline
Quality, Qualified Person
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Job description:
 

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 Qualified Person to join the team.  The purpose of this role is performing batch certification and helping to direct organisational and operational Quality activities.

 

Your responsibilities in this role would be:

 

  • Responsible for certifying that Investigative Medicinal Products (IMPs) and or commercial API are manufactured in accordance with GMP
  • Member of Quality Leadership / Steering Team
  • Input on quality policy, objectives and deliverables for business.
  • Input on quality decisions and go-forward strategy, balancing quality with business objectives
  • Participation at project meetings, client / partner meetings
  • Be a key point of contact for external parties for quality.
  • Serving as EU Qualified Person (QP) for batch certifications in accordance with 2001/83/EC, 2001/20/EC and SI2012-1916
  • Overseeing BMR and supporting record review and approval (deviations, EM, analytical, OOS/OOT etc)
  • Providing guidance and integration of European and USA regulations
  • Ensuring GMP knowledge of self and others within both the Quality team and other function are kept up to date.
  • Participate as required in self-inspection activities and external audits
  • Host and support regulatory inspections, audits by clients / partners.
  • Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex16)

 

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

 

  • Life Science degree and / or post graduate
  • Must meet eligibility requirements combined with relevant biologics and steriles knowledge to be named on Manufacturer’s Authorisation for IMPs (or commercial API) from MHRA
  • Detailed knowledge of Guide to Good Manufacturing Practice
  • Expert knowledge of Validation and Quality Management systems
  • Working knowledge of Clinical Trials and IMP Regulatory system
  • Meets requirements of continuing professional development required to maintain QP status
  • Meets requirements of the Qualified Person as detailed in articles 49 and 50 of Directive 2001/83/EU and Medicines for Human Use (Clinical Trials) Regulation 2004
  • Extensive knowledge, interpretation and application of quality management within a GxP  environment for early phase clinical trials 
  • Experienced Pharmaceutical Auditor
  • Experience hosting regulatory inspections
  • Experience of managing/leading others

 

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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert