TasksThe Global Clinical Operations, Inspection Readiness Lead will provide support during
regulatory inspections and internal audits. This individual will also work to ensure that all
identified content is organized, current and readily accessible in the event of an inspection or
audit purposes. Additionally, the individual will work with department leaders to build an
inspection readiness capability across the organization.
- Lead inspection readiness activities across the Global Clinical Operations (GCO) organization and collaborate with Quality Assurance to ensure alignment acrossthe organization.
- Enhance, maintain, and update the GCO inspection readiness “game-plan” to ensure GCO operates with an always inspection ready mindset.
- Lead the clinical study teams through inspection readiness preparation activities.
- Establish, lead and support routine gap analysis of GCO processes and lead the efforts in preparing a strategy for correction.
- Actively assist with regulatory authority inspections, including the drafting of responses pertaining to GCO.
- Create and prepare monthly, quarterly, and annual status updates with regards to
inspection readiness activities.
- Partner with Quality Assurance and GCO teams to establish roles and responsibilities for
- Inspection Readiness, ensuring consistency across global inspections.
- Facilitate strategic planning for GCO Inspection Readiness (site specific Inspection Plans,Roles and Responsibilities Schedule, Inspection Logistics and Training), and reporting/escalation of opportunities
for process performance improvements or risk mitigation activities.
- Assure effective communication tools, including structured meetings are established and maintained.
- Develop effective metrics and monitoring programs to assure constant vigilance with respect to Inspection Readiness Activities.
- Support developing GCO specific Inspection Readiness training program.
- Conduct education programs regarding Industry and Compliance trends.
Qualifications- Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently.
- Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
- Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret
- Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback;
- Contributes to building a positive team spirit; Puts success of team above own interests;
- Supports everyone's efforts to succeed. Contributes to building a positive team spirit;
- Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or
- Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals;
Completes tasks on time or notifies appropriate person with an alternate plan.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
- Project Management - Communicates changes and progress; Completes projects on time and budget.
- 10+ years of relevant experience