Beschreibung

In this role, you will oversee quality assurance for Contract Manufacturing Organizations across the EMEA region, ensuring compliance and fostering strong relationships with key partners. Your daily responsibilities will include developing quality agreements, resolving issues, and collaborating with cross-functional teams to maintain high standards.

Anforderungen

• •Four-year degree in relevant business or science, or equivalent education and experience
• •Minimum of 5 years’ experience in GxP environment in pharmaceutical industry
• •Thorough understanding of required regulations including FDA, PiC/S, European regulation, Therapeutics Goods Authority, Canadian Health Authority
• •Strong industry and quality system knowledge
• •Comfortable working in a global, matrix organization
• •Experience in CMO business highly preferred
• •Strong organizational skills
• •Fluency in English (written and spoken); German knowledge is a plus

Aufgaben

• •Manage production efforts at Contract Manufacturing Organizations (CMOs)
• •Provide quality oversight for outsourced operational activities
• •Develop and enforce Quality Agreements
• •Support CMO Changes and Deviations
• •Resolve quality issues
• •Review Quality Performance KPIs
• •Establish collaborative relationships with CMO and CSL stakeholders
• •Initiate and negotiate CMO Quality Agreements
• •Oversee and report CMO quality performance
• •Escalate quality issues to key stakeholders
• •Maintain standardized Quality Oversight processes
• •Represent QA in cross-functional project teams
• •Provide on-site presence at CMOs as needed
• •Manage intake of new CMO projects and initiatives