Website Lenox Executive Search
Lenox Executive Search is seeking an experienced Compliance Manager for GCP Inspection Readiness to fill a 6+ month extendable contractual role with a large, global pharmaceutical company. Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field.
Manage and/or lead cross functional study execution teams in regulatory inspection readiness activities focused on clinical trial delivery process and functional area compliance. Coordinate storyboard development with cross functional team, focusing on high risk and/or high impact areas
Create documentation, such as plans, timelines, progress reports, measuring compliance and quality communicating actions to stakeholders
RESPONSIBILITIES of the Compliance Manager (GCP Inspection Readiness):
- Serve as functional area compliance contact for Quality led internal audits and regulatory inspections
- Active participation on Quality Inspection meetings, ensuring timely completion of deliverables as per agreed upon timelines
- Interface with cross functional subject matter experts and Quality in preparation for audit and inspection planning, implementation, and follow-up
- Compliance and Deviation Management
- Manage quality investigations, as appropriate, with cross functional teams to determine root cause and overall impact
- Support study execution teams on compliance to clinical trial delivery SOPs; manage and report non-compliance
- Identify and highlight risks and issues within project(s) and escalate appropriately. Identify, develop, and implement effective
mitigation and escalation strategies for projects to address risks and issues.
- Manage CAPA, EC tracking for supported functional areas
- Manage non-compliance including deviation determination, documentation, liaising with Quality
- Accountable for implementing effective strategies for cross functional team performance; ability to make decisions for designated function
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Effectively resolve conflict in a constructive manner
- Ability to work in a global ecosystem (internal)
- Ability to take risks implementing innovative solutions; comfortable with flexibility to adapt to changing environment.
REQUIREMENTS of the Compliance Manager (GCP Inspection Readiness):
- Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of clinical trial management and/or GCP compliance processes
- Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trials and industry best practices
- BS, MS or equivalent in scientific field
- Solid knowledge of drug development and clinical trial processes, including related standards and documents.
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
- Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc)
- Demonstrated ability to work across functions, regions and cultures
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can engender credibility and confidence within the company
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization