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Expired
  • Location: Harwell
  • Salary: Up to £55,000 + Bonus + Stock Options + Excellent Benefits
  • Job Type:Permanent

Posted over 1 year ago

  • Sector: Quality, Clinical Operations
  • Contact: Steve Twinley
  • Contact Email: steve.twinley@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2022-09-14
  • Job Ref: V-47493
Are you passionate about developing a positive Quality culture, utilising your expertise in GCP? Do you have a strong background in QA from a Biotech or Pharmaceutical environment, backed with a Biological Science education (or similar) and a good grasp of GCP, alongside broader GXP? If so, this newly-created position for a Quality Manager could be an exciting career step for you!
 
This is a permanent position, based in the South of Oxfordshire, with an innovative clinical-stage biotech company who have a development portfolio of a few products and collaborate with a range of academic and commercial organisations. They have an instrumental role in the field of pioneering vaccines and immunotherapies, and are at a stage now where they need to expand their Quality function by hiring a Quality Manager, reporting to the Director of Quality.
 
You will be paid a very competitive salary, in the region of £50k-£55k and with discussion available depending on your experience. The company also offers an excellent benefits package (see below), including stock options and annual bonus, and you will be able to work on a flexible, hybrid basis (e.g. 3 days in the office, 2 days from home).
 
We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are developing new approaches to collaboration, manufacturing and clinical development.
 
Your role will include:
 
  • Supporting the Director of Quality in the management and development of the QMS, including SOPs, Deviations, CAPAs, Change Controls, Audits and Risk Assessments
  • Ensuring GCP and GMP are followed and promoted across the organisation
  • Managing the study-specific Audit programme
  • Performing internal and external Audits
  • Auditing key documents including validation reports, regulatory submissions, clinical documents, clinical study reports etc
  • Co-ordinating the risk-based annual audit programme for 3rd party collaborators and maintaining the Approved Supplier List
  • Growing the Quality team and line-managing new QA staff
  • Delivering Quality training to staff, including induction and refresher training for GCP and GMP
  • Establishing KPIs and producing regular Quality Reports
  • Acting as Quality Representative for all tasks defined in QMS documents
  • Deputising for the Director of Quality when required
 
You will join a small QA team which is going to be growing, under your guidance.. As such, this will be a fantastic career opportunity, not only to be a part of a growing a cutting-edge biotech business but also to develop your GCP and GMP knowledge, with involvement in all areas of QA management.
 
Benefits:
 
In addition to a highly competitive salary (£50k - £55k depending on experience), you will also receive a discretionary annual bonus, stock options, 25 days’ holiday (which increases each year), private healthcare, life insurance and pension.
 
Skills and Experience Required:
 
  • Life science qualification – ideally a degree minimum (preferably a Masters or PhD) in a biological science
  • A passion for Quality and developing QA / QMS processes
  • Strong knowledge of GCP. Other knowledge such as GMP, and GCP for labs, will be highly desirable
  • Experience of team leadership and training, with a supportive and nurturing leadership style
  • Excellent communication skills and ability to work with people at all levels
  • Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
 
This is a permanent position in Harwell, South Oxfordshire, with hybrid working available. Full details will be provided on application – please get in touch to find out more!