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Quality Assurance (QA) Operations Team Lead

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
13 Sep 2021
Closing date
13 Oct 2021

View more

Discipline
Quality, GMP, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
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 (QA) team is responsible for the company’s 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 Team Leader to manage a team of Senior QA officers and QA officers.  The role will also require you to lead, co-ordinate and perform the day-to-day QA Operation activities and tasks, to meet the scheduled timelines in line with manufacturing and supporting function activities whilst ensuring regulatory compliance and industry expectations.

 

Your responsibilities in this role would be:

  • Lead and be accountable for the performance of a team of Senior QA officers and QA officers.
  • Resource plan and maintain visibility of the team’s workload, ensuring completion of activities assigned to direct reports to achieve team and business goals
  • Coordinates daily team workload & serves as first point of contact to other OXB departments/stakeholders
  • Reviewing / auditing documents generated during the Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain GxP processes
  • Writing, reviewing and approving SOPs, Risk Assessments, Deviation, Change Control & CAPA records.
  • Proactively identifying improved ways of working within QA Operations & the wider QMS / PQS
  • Supporting Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain teams by providing Quality Assurance input and guidance on regulatory requirements and industry expectations
  • Assuring compliance to EU and US FDA GxP, Company QMS and QA GMP Operations and any other applicable regulations / standards
  • Ensures that team’s work complies with cGMP, Data Integrity & Good Documentation Practices
  • Assist in preparation of areas and QMS processes for inspections (Regulatory, Client and internal)
  • Participation in regulatory and client GMP audits and internal Self Inspection program
  • Participation in Client projects and programs
  • Providing Leadership, coaching, performance feedback and training to all direct reports
  • Back up/deputise for QA Operations Manager 

 

 


Profile description:

 

 

 

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

 

 

  • Science based degree.
  • Substantial experience working in a pharmaceutical quality function
  • Experience of working within a Sterile / Aseptic GMP manufacturing environment is preferable.
  • Very good knowledge of the principles and guidelines for GMP/Regulatory requirements
  • Leadership and Management of small teams
  • The ability to lead, perform and train QA processes.
  • The ability to participate in Regulatory / Customer Audits. Experience with client interaction
  • Thorough understanding of equipment qualification and process validation.
  • Strong IT skills, including MS Office – Word, Explorer, Excel, Access, Outlook.
  • Thorough understanding of equipment qualification and process validation.

 

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

 

No Agencies please

 


We offer:

 

 

 

We are committed to offering highly competitive reward packages for all our staff. That’s why, every year, we benchmark our salaries and benefits against the local pharmaceutical market – by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.

 

 

We’re looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It’s no mean feat, and we have to work together to make this happen.

Along the way, you’ll have a rich variety of opportunities to really develop your career. We’ll also give you a generous set of employee benefits and a competitive salary.

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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