Senior Compliance Manager
The Senior Compliance Manager is responsible for mentoring and coaching compliance managers, creating/executing the vision, strategy & objectives for the GCP Compliance group, ensuring proactive compliance and inspection readiness are integrated into planning and execution of clinical trials and supporting audit/regulatory inspection(s).
The Senior Compliance Manger provides guidance to functional/clinical trial and program teams on Clinical Trial Quality Risk Management (CTQRM) and GCP related activities/issues.
Key responsibilities:
• Provide coaching, guidance, and mentorship to compliance managers
• Support to create the vision, strategy & objectives for GCP Compliance group and independently develop and execute initiatives & activities to deliver against defined vision & objectives
• Operational oversight of outsourced monitoring activities, including CRO/site oversight visits as a study compliance manager to ensure proactive risk & compliance activities are integrated into planning and execution of assigned clinical trial(s)
• Identify and anticipate quality issue trends and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion
• Provide support and guidance to functional/clinical trial teams in drafting responses to address audit/inspection findings
• Lead/support inspection readiness activities in close collaboration with Clinical Quality Assurance and ensure clinical trial team members are trained and prepared for regulatory inspections
• Conduct pre-inspection visits at investigational sites/third party vendors to support inspection readiness activities
• Provide guidance on regulations, GCP and other guidelines to functional/clinical trial and program teams.
• Maintain or update Standard Operating Procedures (SOPs), Working Practices (WPs) and Policy Documents in the area of compliance
Bachelor’s degree or equivalent qualification in life science/healthcare, Master's degree is preferred
• At least 8 years clinical/industry/health authority experience, including at least 3 years with focus on quality and compliance (GCP auditor background preferred)
• In-depth knowledge of current regulatory and ICH GCP requirements. Strong experience of CAPA management, risk management and audits/regulatory inspections (e.g. FDA, EMEA)
• Experience in contributing to or authoring Standard Operating Procedures (SOPs), Working Practices (WPs) and job aids.
• Experience leading or participating in process improvement initiatives.
• Strong interpersonal, problem-solving, negotiation and conflict resolution skills
• Strong project management and organizational skills
• Very good written and verbal communication
• Effective in establishing and maintaining good collaborations across functions, business units and external partners
• Has a growth mindset
• Willing to travel (approximately 30%)