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Quality Assurance Director

2 months ago

Wrexham, Wrexham, United Kingdom Meet Full time
About the Role

We are seeking a highly skilled Quality Assurance Lead to join our dynamic QA Operations department. As a key member of our team, you will play a pivotal role in ensuring the highest standards of quality across our manufacturing processes.

This is an exciting opportunity to work in a state-of-the-art facility, overseeing and supporting a wide range of activities, from drug substance production to biologics development, and engineering validations.

Key Responsibilities
  • Quality Guidance and Solutions: Provide expert quality guidance and solutions based on a deep understanding of GMP, QRM, and relevant manufacturing processes.
  • Process Improvement: Lead initiatives to enhance practices and procedures, ensuring alignment with GMP requirements for sterile medicinal products.
  • Critical Quality Documentation: Take charge of critical quality documentation, including review and approval of all drug substance release materials.
  • Collaboration and Communication: Liaise with leadership and cross-functional teams, providing expert opinions and contributing to key quality discussions.
  • Subject Matter Expertise: Serve as a trusted SME within QA, offering coaching and learning opportunities to drive continuous improvement.
  • Deputy Role: Act as a deputy for the QA Operations Process Leader when needed, ensuring seamless quality operations.
Requirements
  • cGMP and QRM Expertise: Extensive knowledge of cGMP and QRM in pharmaceutical manufacturing.
  • Organizational Skills: Exceptional organizational skills, with the ability to prioritize, manage time, and assess risk effectively.
  • Communication and Collaboration: A logical, process-oriented thinker with strong communication skills, capable of working collaboratively in a team.
  • Quality Improvement: Proficiency in evaluation and root cause analysis, with a track record of leading quality improvements.
  • Quality Event Management: Ability to be a point of contact for quality events and escalations, providing expert guidance and solutions.
About Us

We are a leading, innovative biopharmaceutical company specializing in cutting-edge therapies with a strong focus on specialty care. Our mission is to put patients first, and we know that the key to achieving this is by empowering our employees. We nurture a culture of boldness, agility, and entrepreneurship, encouraging our team to take ownership and make a tangible difference in the world.