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A global pharmaceutical leader and the world’s largest generic medicines producer Teva Pharmaceutical is looking for a Senior Director of Quality Global Audits who will provide leadership and overall strategic direction to the Regional hub audit leaders to ensure compliance with regulatory requirements as well as alignment with company objectives and Quality standards.
Job Description
Global Lead Quality Audits will provide leadership and overall strategic direction to the Regional hub audit leaders to ensure compliance with regulatory requirements as well as alignment with company objectives and Quality standards. As dynamic, resourceful and strategic thinker he/she will provide results-oriented leadership to sustain and improve a world class robust and efficient Global Quality Audit Program and related Regional Quality Audit organization. This role is a member of Quality Compliance leadership team reporting to Vice President of Quality Global Compliance and will supervise a global audit organization, encompassing quality oversight by the global audit program over product development units, all manufacturing sites in Teva Global Operations Pharma and Teva api, Commercial Quality units, TGO Laboratories, Distribution Centers, and the global supplier network including Third party product contract manufacturer and their supplier network.
Provide strategic leadership and direction to the Global Quality audit program and its organization, to ensure compliance to the TEVA QMS across the TEVA manufacturing network and its suppliers and compliance to regulations which apply to the audited organization. The audit program should take into account emerging trends by regulators that lead to enforcement and these areas should be included in the audit process.
Qualifications
BSs or advanced degree in Science, Quality Management or related discipline.
Advanced degree preferred (MS, PhD, MBA)
Fifteen (15+) years of experience in quality assurance, quality systems, and/or compliance role, medical device quality operations.
Deep understanding and strong connections to the Health Authorities across the globe, not limited to US FDA with either of the diverse global authority, e.g. MHRA, EMA, AIFA).
Significant, direct interaction with world-wide health authorities.
Thorough knowledge and understanding in Quality and operation processes along the entire business value chain
Deep knowledge of global regulations impacting Teva’s business, with the ability to interpret and apply those requirements, e.g. ICH-, US FDA-, EMA-, MOH Russia guidelines for APIs and typical pharmaceutical dosage forms (oral, sterile, patches, combination products) and medical devices (e.g. pens).
