Director of Quality Systems Compliance

1 month ago


Oxford, Oxfordshire, United Kingdom OXB Full time

OXB, a quality and innovation-led viral vector CDMO, is seeking a Director of Quality Systems Compliance to lead the company's quality processes and systems compliance with GMP guidelines.

The successful candidate will be responsible for maintaining GXP regulations compliance support and guidance to OXB GXP functions. This includes leading internal and external audits, quality compliance, and control.

Key responsibilities include:

  • Partnering with the business to ensure procedures align with regulatory and industry expectations, ensuring consistency across functions.
  • Promoting a positive QA culture and providing QA direction for business and operational decisions.
  • Developing and performance managing a high-performing team of Quality Officers, providing coaching/mentoring as needed.
  • Working with GXP functions to maintain and improve the quality system for low bioburden and sterile products development, manufacture, and analytical testing.
  • Providing oversight of quality metrics, identifying training needs, and trending quality metrics.
  • Communicating quality metrics, actions, and recommendations at Quality Review Management Forum.
  • Identifying and leading process improvement projects impacting multiple functional areas.
  • Responsible for Quality Systems Officers performance management and mentoring/coaching as needed.

We are looking for:

  • BSc Degree in a relevant scientific discipline with several years of technical and quality experience in the biopharmaceutical industry.
  • Management/Leadership experience in Quality Management Systems (QMS)/Pharmaceutical Quality Systems (PQS).
  • Strong working knowledge of local and international GXP regulations, able to interpret these requirements.

In return, you can expect:

  • A highly competitive total reward package, including a salary range of £80,000 - £110,000 per annum.
  • Wellbeing programs to support your physical and mental health.
  • Development opportunities to enhance your skills and career progression.
  • State-of-the-art laboratory and manufacturing facilities.


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