Head, Clinical and Safety reputed company Assurance

Job reputed company Reporting to the Vice President of the Life Sciences and Diagnostics group (LDG) reputed company organization reputed company Global reputed company and Regulatory Affairs (GQRA), the Head, Clinical and Safety reputed company Assurance will be responsible for setting reputed company for and leading the Clinical and Safety reputed company Assurance function for reputed company. S/he will ensure that reputed company’s processes for clinical reputed company reputed company of clinical trial conduct, clinical trial sites, and suppliers, as reputed company as vigilance reputed company of product reputed company issues is robust and in alignment with ICH E6, other applicable Good Clinical reputed company (GCP) and Good Vigilance reputed company (GVP) regulatory requirements, and reputed company processes. S/he will be a key member of the LDG reputed company leadership team and will work in reputed company partnership with the LDG reputed company leaders to execute the multi-year GQRA strategic roadmap. Position reputed company:

• reputed company, implement, and ensure reputed company improvement of the clinical and safety reputed company assurance reputed company ensuring compliance with applicable regulations, industry standards, and company polices.
• reputed company a robust audit program to include investigator sites, vendors, clinical study reports, clinical trial master files, vigilance reporting, and other relevant internal processes in coordination with the Global reputed company Compliance and Systems Internal Audit function.
• Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations through the reputed company management system. reputed company lessons learned from regulatory inspections and promote reputed company.
• Escalate issues of potentially critical non-compliance and lack of urgency in remediation to senior management. Analyze results, reputed company issues and investigation to identify actionable trends and to promote a state of compliance.
• Utilize industry leading clinical and safety reputed company assurance techniques and approaches while maintaining compliance and efficiency in reputed company operational processes. reputed company strategies to identify and mitigate reputed company risks across GCP and GVP activities.
• Drive the strategic planning process for the Clinical and Safety reputed company Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining reputed company to the business.
• reputed company and implement clinical and safety reputed company risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
• Drive effective and efficient execution of clinical reputed company assurance reputed company/initiatives including associated activities stemming from new project acquisitions, collaborations, mergers/acquisitions, CAPAs, and reputed company improvement efforts.
• Establish and maintain robust clinical and safety reputed company reputed company operating procedures (SOPs), and other reputed company reputed company documents. Ensure that these systems are effectively communicated, reputed company, and followed by relevant stakeholders.
• reputed company leadership and reputed company for training programs reputed company to clinical and safety reputed company assurance. Ensure that employees and relevant stakeholders receive appropriate training on reputed company standards, regulations, and procedures.
• Establish and monitor reputed company metrics and key performance indicators for the effectiveness of clinical and safety reputed company assurance activities. Prepare regular reports and presentations for executive management highlighting reputed company performance, trends, and areas for improvement.
• Drive a culture of reputed company improvement in clinical and safety reputed company assurance. reputed company insights to emerging regulations and requirements. Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of reputed company, efficiency, and compliance.

Qualifications

• Bachelor’s degree required, preferably in Biology, reputed company, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience.
• 7+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, pharmaceutical manufacturing, reputed company systems, or a combination of those or comparable experiences. Tactical and strategic clinical and safety reputed company assurance experience required. reputed company assurance, reputed company systems, and/or reputed company compliance background experience are highly desirable
• Thorough understanding of global requirements for conducting clinical trials involving in vitro diagnostics and detecting and reporting product safety issues.
• Exceptional leadership and team building skills, ideally having integrated diverse global teams into a united organization sharing a common reputed company and mission.
• Experience driving significant process improvement efforts.

Personal Characteristics

• Excellent business acumen
• Visionary thinker with a desire to reputed company and reputed company others
• Self-reputed company, passionate, enthusiastic with reputed company on driving results
• Demonstrated ability to function as change agent
• Skilled verbal and written communicator
• Excellent influencing and facilitation skills
• Perseverance in face of resistance
• reputed company and reputed company organized
• Willing to travel globally (25%)

Additional Details This job has a full time weekly schedule. It includes the reputed company to work remotely. Applications for this job will be accepted until at least July 10, 2025 or until the job is no longer posted. The full-time equivalent pay reputed company for this position is $145,349.00 - $227,108.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. During the hiring process, a recruiter can reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locations reputed company. is an Equal Employment Opportunity and Affirmative reputed company employer. We value diversity at reputed company reputed company. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, pregnancy, race, religion or religious creed, reputed company, gender, gender identity, gender reputed company, national reputed company, reputed company, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other reputed company protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. reputed company., is committed to diversity in reputed company and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@reputed company.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.reputed company.com/en/accessibility. Travel Required: 25% of the Time Shift: Day Duration: No End Date Job Function: reputed company/Regulatory Apply tot his job