Senior GCP Compliance Auditor (all genders) (permanent / full-time)

at  AbbVie

Unternehmensbeschreibung
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Stellenbeschreibung

QUALIFIKATIONEN

• Bachelor’s Degree or equivalent education and typically, 12 years of experience, Master’s Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
• Degree in a physical science, life science, nursing, pharmacy, or equivalent experience required
• 5-7 years of pharmaceutical industry experience in Quality Assurance I Regulatory Affairs
• 5-7 years of clinical research and development
• Minimum 2 years of QA auditing experience (GCP Auditing preferred)
• Ability to work independently as well as a team member

• Interpret, explain, and apply the applicable current regulations, guidelines, policies, and procedures
• Familiarity with global electronic records/electronic signature and data integrity requirements preferred
• Plan, organize and lead audits to evaluate vendor R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable regulations globally
• Lead or participate in investigator site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements
• Lead Global System and Supplier Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations
• Effectively communicate audit results, both orally and in writing
• Review corrective action plans/audit responses for adequacy and approve if adequate
• Evaluate the potential risk of compliance deficiencies
• Review policies and procedures and suggest improvements
• Maintain effective communication of project related information
• Provide training and consulting services to the organization to ensure GCP compliance
• Escalate potential quality issues to management
• Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality