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QA Team Leader

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
4 Aug 2022
Closing date
3 Sep 2022

View more

Discipline
Quality, QA / QC, R & D , Biotechnology
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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Job Details

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.

 

 

Company

About us

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.

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.

Find Us
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom
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