Senior Quality Assurance Manager
Cure Talent is excited to be working with a global pharmaceutical and CDMO organisation renowned for their respiratory product expertise.
The company continues to invest in the growth and transformation of their site, creating an exciting opportunity for a Senior Quality Assurance Manager to join their Site Leadership Team.
* This high-impact role plays a key strategic and operational role, responsible for the overall direction and performance of QA and QC across a site of 85 quality professionals.
* You'll lead a department that is lab-heavy, technically strong and undergoing a shift from big pharma to agile CDMO.
This Senior Quality Assurance Manager will bring substantial leadership experience within a GMP pharmaceutical environment. You'll have a strong grasp of both QA and QC operations, including NPI, validation, regulatory inspections (including MHRA and FDA), and CI initiatives.
Key Responsibilities:
1. Set and deliver the site's Quality strategy in line with ICH Q10 and cGMP requirements.
2. Lead the QA, QC, Quality Systems and Support teams, ensuring performance, development, and succession planning.
3. Provide technical leadership across product lifecycle management, tech transfer, validation, and audit readiness.
4. Act as the quality representative on the Site Leadership Team, influencing strategic decisions and site roadmap planning.
5. Host regulatory and customer audits, ensuring a culture of continuous improvement and compliance.
6. Champion practical, commercially minded approaches to quality within an agile, fast-paced CDMO environment.
About the Role:
* Degree educated in a scientific discipline.
* Significant experience leading QA/QC in a GMP pharmaceutical setting.
* Strong technical foundation with a hands-on, lab-focused understanding of Quality operations.
* Proven ability to challenge established processes and implement pragmatic improvements.
* Experienced in managing large teams and operating at senior leadership level.
* CDMO experience is highly advantageous; experience in Agile environments is a plus.
* QP eligibility is a nice-to-have, but not essential.
This is a high-profile position that requires a talented and experienced individual who can shape the future of quality in a transitioning CDMO environment.