Overview of your responsibilities:
* Lead site QA for DS/DP manufacturing, overseeing quality monitoring and participating in GMP activities like process transfer and validation.
* 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.
You will also be responsible for conducting routine audits to ensure compliance with regulatory and company standards. Additionally, you will need to demonstrate strong communication skills and ability to thrive in a matrix environment.
Requirements
* Knowledge of legislative, regulatory, market, biologics, and data integrity requirements.
* Degree in Biopharmaceutical Science or related field.
* Experience in vaccine/biopharma or similar pharma/science roles preferred.
* Demonstrated leadership with over 5 years of management experience.
This role requires someone who is well-organized, proactive, and able to prioritize tasks effectively. If you have a passion for quality assurance and are looking for a challenging role, please consider applying for this position.