QA Team Leader, Analytics

2 weeks ago

Oxford, United Kingdom Oxford BioMedica (UK) Limited Full time

Job description:
 

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

 

We are currently recruiting for a QA Analytics Team Leader to join the Quality Assurance Analytics team.  The purpose of this role is to lead, co-ordinate and perform the day-to-day QA Analytics activities and tasks, to meet the scheduled timelines in line with batch release and stability testing timelines and supporting function activities whilst ensuring regulatory compliance and industry expectations. 

 

Quality Assurance takes into account anything that could affect a drug’s quality during its research, development, and manufacturing phases. We work across the whole product lifecycle. Our expertise spans all the good practice quality guidelines and regulations. We partner with most functions in the business. We make sure activities, processes and procedures satisfy product quality, patient safety, and efficacy needs. We help the business to adhere to current good practice quality guidelines and regulations, Regulatory and Product license, and registered detail requirements. 

 

Your responsibilities in this role would be: 

 

Lead and be accountable for the performance of a team of Senior QA officers and QA officers to support GMP Analytical operations and ensure timely delivery of quality documents for internal and external clients.  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 by stakeholder departments. Timely closure of data packages and QMS records to support batch release and core KPIs.  Reviewing and approving documentation generated for regulatory submissions, as required. Assuring compliance to EU and US FDA GxP, Company QMS and QA GMP Operations and any other applicable regulations / standards. Ability to interpret and apply cGMP regulations consistently.  Promote continuous improvement initiatives to enhance working practices and to mitigate quality risks. Participation in regulatory and client GMP audits and internal Self Inspection program.  Participation in Client projects and programs.  

 

 

We are looking for: 

 

Science based degree (or equivalent experience). Substantial experience working in a pharmaceutical quality function. Experience of working within a Sterile / Aseptic GMP manufacturing environment is preferable.  Experience within Biologics and/or Cell/Gene Therapy / pharmaceutical manufacturing/ Laboratories desirable. In depth knowledge of cGxP, EU & US FDA regulations and product lifecycle applicable to ATMPs, biologics, cell/gene therapy, or pharmaceuticals. Leadership and Management of small teams Experience with Regulatory / Customer Audits. Experience with client interaction desirable. Proactive approach to work. Pragmatic approach to quality oversight.  Demonstrable ability to make sound risk based decisions. Experience in lean/removal of non-value add tasks/activities.

 

 

About Us: 

 

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

 

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.

 

 

What’s in it for you:

 

Highly competitive reward packages Wellbeing programmes Development opportunities Welcoming, friendly, supportive colleagues A diverse and inclusive working environment Our values are: Deliver Innovation, Be Inspiring and Have Integrity State of the art laboratory and manufacturing facilities 

 

Collaborate. Contribute. Change lives

 


Profile description:

 

 

 

We are looking for: 

 

 

 

Science based degree (or equivalent experience). Substantial experience working in a pharmaceutical quality function. Experience of working within a Sterile / Aseptic GMP manufacturing environment is preferable.  Experience within Biologics and/or Cell/Gene Therapy / pharmaceutical manufacturing/ Laboratories desirable. In depth knowledge of cGxP, EU & US FDA regulations and product lifecycle applicable to ATMPs, biologics, cell/gene therapy, or pharmaceuticals. Leadership and Management of small teams Experience with Regulatory / Customer Audits. Experience with client interaction desirable. Proactive approach to work. Pragmatic approach to quality oversight.  Demonstrable ability to make sound risk based decisions. Experience in lean/removal of non-value add tasks/activities.

 

 

About Us: 

 

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

 

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.

 

 

What’s in it for you:

 

Highly competitive reward packages Wellbeing programmes Development opportunities Welcoming, friendly, supportive colleagues A diverse and inclusive working environment Our values are: Deliver Innovation, Be Inspiring and Have Integrity State of the art laboratory and manufacturing facilities 

 

Collaborate. Contribute. Change lives

 


We offer:

 

 

 

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.

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