Quality Assurance Lead
2 months ago
QA Lead (Drug Substance)
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. Join us in making an impact on people's lives, while thriving in a workplace that values your growth and well-being.
About the Role:
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.
Your expertise will be integral in maintaining compliance, driving improvements, and acting as a Subject Matter Expert (SME) across the product lifecycle.
Key Responsibilities:
- Provide expert quality guidance and solutions based on a deep understanding of GMP, QRM, and relevant manufacturing processes.
- Lead initiatives to enhance practices and procedures, ensuring alignment with GMP requirements for sterile medicinal products.
- 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.
Who We’re Looking For:
- Extensive knowledge of cGMP and QRM in pharmaceutical manufacturing.
- Exceptional organizational skills, with the ability to prioritize, manage time, and assess risk effectively.
- A logical, process-oriented thinker with strong communication skills, capable of working collaboratively in a team.
- 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.
Why Join Us?
- 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.
- Join a workplace recognized as a ‘Best Workplace’ and ‘Best Workplace for Wellbeing,’ with a genuine commitment to sustainability, powered by 100% renewable energy.
Make a difference with us—apply today and join a company where your expertise will be valued and your contributions will shape the future of healthcare.
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