QA Team Leader

Job description:

Join Us in Changing Lives

AtOXB , our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful .

We are currently recruiting for a QA Team Leader to join the Quality Assurance team. In this role, you will lead, co-ordinate and perform the day-to-day QA activities and tasks, to meet the scheduled timelines in line with manufacturing, testing and supporting function activities whilst ensuring regulatory compliance and industry expectations, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Leading and being accountable for the performance of a team of QA Officers that support GMP, GLP & GCP (Labs) operations.
• Resource planning and maintaining visibility of the team’s workload, ensuring completion of activities assigned to direct reports to achieve team and business goals.
• The reviewing / auditing documents generated during the Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain GxP processes.
• Managing and delivering timely closure of BMRs and/or analytical data packages and QMS records to support batch release and core KPIs.
• Reviewing and approving internal QA documentation and documentation generated for regulatory submissions, as required.
• Providing input and guidance to OXB functions 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. Ability to interpret and apply cGMP regulations consistently.
• Acting as QA representative during Regulatory Inspections and Client &/or Internal audits.
• Participating in client projects and programs.

Profile description:

We are looking for:

• Science based degree.
• Substantial experience working in a pharmaceutical quality function.
• Experience within Biologics and/or Cell/Gene Therapy / pharmaceutical manufacturing/ Laboratories (desirable)
• Experience of working within a Sterile / Aseptic GMP manufacturing environment is (desirable)
• In depth knowledge of cGxP, EU & US FDA regulations and product lifecycle applicable to ATMPs, biologics, cell/gene therapy, or pharmaceuticals.
• Previous experience of supervising or management of small teams including capable to lead, perform and train QA processes.
• Strong IT literacy ideally with prior experience with LIMS along with MS Office applications.
• Ability to lead and participate in Regulatory / Customer Audits.
• Previous experience with communicating and delivering to clients.

About Us:

OXB 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.

OXB 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. OXB’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.

Why Join Us?

• Competitive total reward packages
• Wellbeing programmesthat support your mental and physical health
• Career development opportunitiesto help you grow and thrive
• Supportive, inclusive, and collaborative culture
• State-of-the-art labs and manufacturing facilities
• A company that lives its values:Responsible, Responsive, Resilient, Respect

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.

Ready to Make a Difference?

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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