Quality Management_ Associate Director(USA Sandoz Inc Princeton NJ) career opportunity in USA

Job title:Quality Management_ Associate Director, North America Clinical QA
Business Unit:Sandoz - Commercial Operations North America
Division:Sandoz
Company/Legal Entity:USA Sandoz Inc Princeton NJ
Deadline: 27/08/2013
Job Reference Code:126250BR
Sandoz, a global leader in the rapidly growing generics industry, is a company in which doctors, pharmacists and patients worldwide have placed their trust for more than 100 years. With our 23,000-plus employees in more than 130 countries, we save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Choosing Sandoz is always "a healthy decision". Through our work and our medicines, we have committed ourselves to improving the quality of life of people the world over. Our future holds many opportunities. Let’s explore them together!
PURPOSE:
Managing pro-actively the activities of the local/ regional activities of the Clinical Quality Assurance in close collaboration with global Clinical Quality Assurance (GCQA) organisation to ensure inspection readiness, a fit for purpose Clinical Quality Management System (QMS), use of Risk Based Approaches to measuring quality and compliance and implementing Continuous Improvement Initiatives.

Responsible for the following: Canada SDC /RCC, US SDC (Fougera).

• Set up, maintenance, improvement of the regional Clinical Quality Management System (e.g. SOPs and local audits/self-inspections) to assure compliance with GCP, applicable regulatory requirements and company standards (e.g. Novartis Quality Modules).
• Distribution of GOPs/SOPs related to studies with humans to all personnel involved in study activities.
• Provides training related to study activities and regulations.
• Internal Consultancy, guidance and support to Sandoz employees on quality and GCP related issues.
• Support of clinical teams regarding audit and inspection readiness.
• Ensures vendor Qualification and adequate vendor audit follow-up.
• Escalation of high risk GCP areas and issues (including inspection announcements) to GCQA.
• Planning of annual internal audits/self-inspections on a local level.
• Host audits and inspections related to study and CQA activities of local site and involvement in Global audits and Health authority inspections as needed.
• Interaction and cooperation with vendor QA personnel, e.g. reviews relevant vendor SOPs.
• Supports, manages and advices on implementation of corrective/preventive actions from audits and inspections, and reported non-compliance issues.
• Conducts audits of local vendors after being qualified /certified.
• Ensure transfer of lessons learned from audits, inspection and non-compliance issues to Clinical Research staff
• Collaborate with other departments within the company which impact study activities,
• Participation in Clinical QA group activities, including interfaces with global CQA managers

Qualifications:
Associates degree in pharmaceutical, medical, nursing, life science or equivalent. Practical experience in clinical research and/or human research activities. Broad knowledge of respective clinical research related regulations including GxPs as applicable

Languages:
English fluent in speaking and writing (French is helpful).
Experience:
Practical, hands-on experience within clinical development area. Experience in clinical QA would be an asset. Experience in an international matrix organisation would be an asset.

Skills:
Excellent intercultural communication and negotiation skills. Team player, Dedicated to quality, Pragmatic, Strong analytical and organisational skills, Attention to details but with an ability to see the overall picture. Willingness to travel- approximately 30%.
Apply on line here