70% Creation and Execution of Internal Audit Program
- Leads the development and execution of the audit activities associated to the internal audit program and the associated regulatory requirements.
- Collaboratively works with QA & Compliance Centers of Excellence (CoE) and key stakeholders from R&D functions across the organization to ensure as robust audit strategy.
- Ensures the appropriate corrective and preventive actions as required are appropriately escalated in a timely manner to the risk council.
- Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.
- As appropriate escalates issues of critical noncompliance and/or lack of urgency in remediation to senior management and risk council as appropriate.
- Participate in CAPA formulation / implementation, Ensure monitoring activities to measure effectiveness. Audit includes applicable processes of R&D functions.
- Collaborates and coordinates process audits with the Heads of R&D QA & Compliance Centers of Excellence.
30% Regulatory Agency Support
Education and Experience Requirements
- Develops and manages the strategies for the preparation, hosting and responses to regulatory agency inspections as appropriate including participation in hosting and management of inspections as required.
- Ensures inspection readiness at all times
Bachelor's degree in a life science required; Master's Degree in management or scientific discipline a plus.
Key Skills, Abilities, and Competencies
- At least 10 years of pharmaceutical experience. 5 years of audit experience
- Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, Drug Safety and auditing.
- Project management, process improvement and / or training experience required.
- Experience working in a Matrix organization required.
Extensive knowledge and/or awareness of GxPs, FDA, EMA and MHRA regulations, ICH Guidelines and European Clinical Trials Directive. Other Job Requirements
Domestic and international travel required. Must travel globally to sites where clinical and pharmavogilance colleagues operate. Must have a global mindset.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.