Site Quality Head

Description

• Build and develop site quality organization of new site to ensure sufficient resource and capabilities in place for the quality operations and continues improvements.
• Set up validation master plan for the project, ensure timely completion of facility/equipment/utilities qualification and process validation.
• Design, establish and implement site quality management system to ensure site operation fully complies with company standards and customer expectations.
• Ensure operational readiness of QC lab to support project qualification, validation activities.
• Assess and approve raw material and service suppliers according to global quality requirements.
• Support tech transfer of products from giving sites and ensure equivalent quality.
• Provide quality oversight of the entire manufacturing site
• Responsible to make quality decision for product disposition.

Qualifications

• Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
• A minimum experience of 15 years, with 5 years of supervisory position, in the pharmaceutical, biotechnology or medical device in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
• Fluent in English.