Associate Director of Quality Assurance (GMP)
An exceptional opportunity to lead a team as an Associate Director of Quality Assurance (GMP) in a renowned Biologics Leader.
Responsibilities
* Oversee site QA for DS/DP manufacturing, ensuring quality monitoring and participation in GMP activities such as process transfer and validation.
* Maintain the highest standards of quality in GMP production facility construction.
* Support CQV activities as required.
* Collaborate on SOP creation and alignment with WuXi corporate policies.
* Audit departmental quality documents for data integrity and provide QA guidance.
* Assist in site GMP Readiness and internal inspections.
* Establish and manage a high-performing DS/DP QA team, providing online support.
* Coordinate with cross-functional teams to support GMP production activities.
* Conduct regular audits to ensure compliance with regulatory and company standards.
Requirements
* Demonstrated knowledge of legislative, regulatory, market, biologics, and data integrity requirements.
* Bachelor's degree in Biopharmaceutical Science or a related field.
* Proven experience in vaccine/biopharma or similar pharma/science roles preferred.
* Excellent communication skills and ability to thrive in a matrix environment.
* Proven leadership with over 5 years of management experience.