Beschreibung

As the Site Quality Head, you will oversee quality assurance and compliance, lead strategic initiatives, and ensure effective communication across projects. This role focuses on maintaining high standards in quality operations while managing critical quality issues and driving team accountability.

Anforderungen

• •BS/MSc in Life Sciences or related experience
• •10 years of experience in GMP Pharmaceutical Manufacturing
• •At least 3 years of relevant experience in Quality Control or Quality Assurance
• •Proven track record in supporting Quality Control operations
• •In-depth knowledge of cGMP and FDA regulations
• •Ability to manage multiple projects with moderate resource requirements
• •Highly developed management and communication skills
• •Strong organizational and time management skills
• •Experience in process improvement approaches

Aufgaben

• •Provide quality assurance oversight
• •Support quality operations
• •Lead technical and strategic quality initiatives
• •Ensure compliance with GxP standards
• •Ensure compliance with cGMP requirements
• •Represent site quality in cross-functional and global project teams
• •Lead and support the Quality Assurance department
• •Ensure team members are qualified and motivated
• •Create user requirements and specifications for projects
• •Liaise with stakeholders for project coordination
• •Ensure facilities and equipment are safe and compliant
• •Oversee project planning, construction, and qualification phases
• •Create and maintain project plans to track progress
• •Escalate risks related to timelines and budgets
• •Manage product critical quality issues and deviations
• •Ensure effective execution of investigations and CAPAs
• •Review and approve compliance-related notifications
• •Define and monitor Site Quality KPIs
• •Establish and support the Site Quality Committee
• •Coordinate Site Quality Plans and risk assessments
• •Prepare and consolidate the Quality Unit budget
• •Ensure adherence to health and safety procedures