Job Title:

Senior QA Specialist I Reports to:

Quality Assurance Manager/ Specialist II Location:

US-CRAN Job Summary:

We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for leading QA projects, ensuring quality and timely delivery. Coordinate cross-functional teams, manage timelines, and ensure GMP compliance. Drive project success through effective communication and risk management.

Key Responsibilities:

• Oversee QA projects, ensuring timely completion and quality
• Coordinate cross-functional teams (QC, Regulatory and other relevant departments etc.)
• Develop and execute project plans, timelines
• Ensure compliance with GMP, regulatory requirements
• Identify and mitigate project risks, track progress
• Collaborate with stakeholders on project scope, changes Support audits and other activities as required.

Requirements:

• Bachelor's/Master's in relevant field (e.g., Life Sciences, Pharmacy)
• 3-5 years in QA/project management, preferably in pharma/biotech
• GMP regulations, project management methodologies
• Strong communication, problem-solving, and organizational skills and Tools such as Project management: Jira, Aspera, MS Project, Document control: SharePoint, Document Vault ( any skill would be a plus) WuXi Biologics is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability