GPS Compliance & Training Manager

This position will provide robust support for activities required during pre-peri and post audits and inspections including pro-active support for Inspection readiness activities. The position will also support activities around the entirety of the GPS Quality Management System as required and maintain centralized GPS service provider business oversight.

Key Activities

• Support the proactive GPS Inspection Readiness program as required
• Support Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Participate and lead compliance activities around any high-risk processes in GPS
• Support and maintain oversight of GPS Service Provider oversight including mitigation of compliance concerns by working with the GPS business process owners (BPOs)
• Liaise with SPMA, GPS BPOs and the service providers for any advanced concerns including CAPAs, Critical audit/inspection findings and compliance concerns
• Support PV Compliance Related activities as required
• Provide project management support across all GPS departments as identified by management
• Advances issues / problems related to on-going projects to senior management in a timely manner and as needed
• Monitor and, as necessary, confirm data accuracy in safety systems for key deliverables
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support management review activities as required
• Support oversight of Global PV Regulatory Intelligence as required
• Provide Project management support and oversight for M&A Safety activities
• Provide support for maintenance of SharePoint sites and other systems as required
• Provide support around GPS training and controlled documents as required
• Provide support around on-boarding, JD/CV maintenance for GPS as required
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by direct supervisor

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is with these qualifications.

Basic Qualifications:

• Doctorate degree

Or

• Masters degree or PMP certification plus 4 years relevant experience

Or

• Bachelors degree & 7 years of directly related experience

Or

• Associates degree & 10 years of directly related experience

Or

• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

• Understanding of Regulatory and Safety functional activities
• Pharmacovigilance Audit & Inspection knowledge
• Vendor Oversight knowledge
• Committed
• Dealing with ambiguity
• Command skills
• Conflict management
• Customer focus
• Managing diversity
• Listening
• Managing and measuring work
• Building effective teams
• Execution of multiple projects in a matrix environment
• Project management
• Industry and/or Regulatory/Safety experience
• Safety Audit and Inspection experience