Job description:
 

We use science to save lives, and so can you. 

We are currently recruiting for a QA Operations Team Leader to join the Quality team.  The purpose of this role is to effectively manage a team of Senior QA officers and QA officers. 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.

The QA Analytics team supports the GxP laboratories located in Oxford. We carry out documentation review, coaching and training and ‘Quality on the Shop Floor’ activities for a wide range of work from research and development, to commercial manufacture.

Specific Work Responsibilities and Deliverables:

• Lead and be accountable for the performance of a team of Senior QA officers and QA officers to support GMP, GLP & GCP (Labs) operations and ensure timely delivery of quality documents for internal and external clients.
• Responsible for ensuring team’s active participation in Oxford Biomedica’s ‘Quality on Shop floor’ program.
• Reviewing / auditing documents generated during the Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain GxP processes (e.g. Deviation, Change Controls, CAPAs, Environmental Monitoring Investigations, OOS Investigations, Validation protocols and Reports, FMS records, Quality Control Assays, Method Validation, Raw Data, Engineering, warehouse and supply chain QMS records).
• 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.
• Act as QA representative during Regulatory Inspections and Client &/or Internal audits.
• Promote continuous improvement initiatives to enhance working practices and to mitigate quality risks.
• Participation in Client projects and programs.
• Provides Leadership, coaching, performance feedback and training to all direct reports (including the following, setting of performance goals and development plans, completing Mid-year and end of year Performance Reviews, actioning Monthly 1 to 1 meetings with direct reports to follow up on performance goals and development plans).

We are looking for someone with: 

• A 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 preferable.
• In depth knowledge of cGxP, EU & US FDA regulations and product lifecycle applicable to ATMPs, biologics, cell/gene therapy, or pharmaceuticals.
• Experience of sterility testing, media fills and fill / finish manufacturing desirable
• Leadership and Management of small teams

About Us:  

We are an innovative leading viral vector specialist focused on delivering life changing therapies to patients. 

Our innovative solutions and proven expertise allow us and our customers, the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients. 

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world’s worst diseases and medical conditions. 

We work together, motivated to make a difference, and so can you.  

What’s in it for you: 

• Highly competitive reward packages 
• Wellbeing programmes 
• Development opportunities 
• A 35-hour working week 
• 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:

We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.

We are pioneers; no one else does what we do.

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.