Job Title: Associate Director of Quality Assurance (GMP)
We are seeking an experienced professional to lead our quality assurance efforts in the GMP production facility.
About the Role:
* Oversee the GMP production quality system, ensuring compliance with regulatory and company standards
* Establish effective monitoring structures to maintain high-quality standards
* Lead site QA for DS/DP manufacturing, overseeing quality monitoring and participating in GMP activities
* Monitor GMP production facility construction quality
* Support CQV activities as required
* Collaborate on SOP creation and alignment with corporate policies
* Audit departmental quality documents for data integrity and provide QA guidance
* Assist in site GMP Readiness and internal inspections
* Establish and manage DS/DP QA team, providing online support
* Coordinate with teams to support GMP production activities
* Conduct routine audits to ensure compliance with regulatory and company standards
Requirements:
* Knowledge of legislative, regulatory, market, biologics, and data integrity requirements
* Bachelor's degree in Biopharmaceutical Science or related field
* Experience in vaccine/biopharma or similar pharma/science roles preferred
* Strong communication skills and ability to thrive in a matrix environment
* Demonstrated leadership with over 5 years of management experience
About Us:
We are a leading biologics company committed to delivering high-quality products that meet customer needs.