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Quality Assurance Operations Manager
2 months ago
Meet our team of dedicated professionals who are passionate about delivering high-quality products that make a real difference in patients' lives.
We are a specialty-driven biopharma company focused on innovation and specialty care, with a strong commitment to our employees, who are the true ambassadors of our mission.
We are seeking a Quality Assurance Operations Manager to join our team in Wrexham, playing a pivotal role in driving quality performance and compliance. As part of the site Quality Leadership Team, you'll be instrumental in setting the strategy, objectives, and goals for our Quality department.
Key Responsibilities:- Establish and maintain an effective QA Operations service for all operations at the Wrexham site, ensuring product quality, compliance, and customer satisfaction.
- Lead and inspire a team of Quality professionals dedicated to achieving site objectives.
- Foster collaborative relationships with BPD Quality and across the organization to fully embed a strong Quality Culture.
- Develop succession plans to ensure continuous QA support and cultivate future talent.
- Build and maintain effective working relationships with regulatory bodies, industry groups, and other sites to meet and exceed regulatory expectations.
- Lead projects focused on continuous improvement, optimizing processes and enhancing performance.
- Develop and manage financial plans to achieve business objectives within budget.
- Actively drive initiatives to improve efficiency and reduce costs.
- Extensive experience in the regulated pharmaceutical industry, with a focus on Quality Assurance, Quality Control, and Manufacturing Operations for Biologics drug substance or drug products, particularly sterile products.
- Proven leadership experience in a QA supervisory or management role.
- Strong knowledge of regulatory requirements (MHRA, FDA, ICH, EMA).
- A collaborative mindset with effective leadership skills.
- Ability to manage multiple priorities in a fast-paced environment.
- A strategic thinker who can navigate complex technical and commercial landscapes.
- Exceptional people management, decision-making, communication, and influencing skills.
- Be part of a rapidly growing business offering a wide range of opportunities and challenges.
- Work on a site benefiting from a major multi-million-pound investment in a New Drug Product Facility, enhancing our capabilities and product offerings.
- Experience a fantastic culture with a long-serving team dedicated to our mission.
- Join a company committed to Diversity & Inclusion, with nearly 50% of our top leaders being women.
- Work for a company that is serious about sustainability, with our Wrexham site powered by 100% renewable electricity.
- Enjoy competitive salaries, an enhanced benefits package, including an annual bonus, generous pension scheme, wellness allowance, and more.
- Be proud to work for a company that directly impacts and improves lives.
