Quality Assurance Team Lead

3 weeks ago

Wrexham Wales, United Kingdom Meet Full time

QA Lead (Drug Substance)
We are a leading, innovative biopharmaceutical company specializing in cutting-edge therapies with a strong focus on specialty care. As the QA Lead within our dynamic QA Operations department, you will play a pivotal role in ensuring the highest standards of quality across our manufacturing processes.
This role is based at our state-of-the-art facility in Wrexham, where you will oversee and support a wide range of activities, from drug substance production to biologics development, and engineering validations.
Provide expert quality guidance and solutions based on a deep understanding of GMP, QRM, and relevant manufacturing processes.
Take charge of critical quality documentation, including review and approval of all drug substance release materials.
Liaise with leadership and cross-functional teams, providing expert opinions and contributing to key quality discussions.
Serve as a trusted SME within QA, offering coaching and learning opportunities to drive continuous improvement.
Act as a deputy for the QA Operations Process Leader when needed, ensuring seamless quality operations.

Extensive knowledge of cGMP and QRM in pharmaceutical manufacturing.
Exceptional organizational skills, with the ability to prioritize, manage time, and assess risk effectively.
Proficiency in evaluation and root cause analysis, with a track record of leading quality improvements.
Ability to be a point of contact for quality events and escalations, providing expert guidance and solutions.

Be part of a rapidly growing company with exciting opportunities for professional development.
Contribute to a major multi-million investment in our Wrexham facility, expanding our capabilities and impact.
Work in a supportive environment with a fantastic culture and a strong commitment to Diversity & Inclusion.
Enjoy a competitive salary and an enhanced benefits package, including an annual bonus, a generous pension scheme, and wellness allowances.

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