About the Role
The Senior Director of Quality Operations is a pivotal position that oversees quality operations for both Drug Substance and Drug Product manufacturing at a biopharmaceutical site.
Key Responsibilities:
* Lead quality operations teams to ensure compliance with regulatory and company standards.
* Support technology transfer, batch release, and site readiness initiatives.
* Develop and manage quality operations processes, fostering accountability and performance excellence.
* Review, approve, and audit manufacturing documentation to ensure regulatory compliance.
* Provide quality guidance across manufacturing and cross-functional teams, supporting compliance and continuous improvement initiatives.
* Support inspections and self-audits, providing coaching and guidance to teams.
Requirements:
* 8 years experience in pharmaceutical manufacturing, with sterile filling experience highly desirable.
* Proven track record in managing teams, mentoring specialists, and driving operational excellence.
* Experience in startup or early-stage facility environments, including GMP readiness and inspections.
* Strong knowledge of European regulations, cGMP, and quality compliance standards.
This role requires a strong leader who can drive quality operations and foster a culture of excellence. The ideal candidate will have a proven track record of managing complex projects, leading teams, and ensuring compliance with regulatory standards.