Head, Clinical and Safety Quality Assurance

Job Description

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

• reputed company, implement, and ensure reputed company improvement of the clinical and safety quality assurance strategy 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 Quality Compliance and Systems Internal Audit function.
• Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations through the quality 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, quality issues and investigation to identify actionable trends and to promote a state of compliance.
• Utilize industry leading clinical and safety quality 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 Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.
• reputed company and implement clinical and safety quality 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 quality assurance projects/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 quality standard operating procedures (SOPs), and other reputed company quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
• Provide leadership and reputed company for training programs reputed company to clinical and safety quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
• Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical and safety quality assurance activities. Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.
• Drive a culture of reputed company improvement in clinical and safety quality assurance. Provide insights to emerging regulations and requirements. Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance.

Qualifications

• Bachelor’s degree required, preferably in Biology, Chemistry, 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, quality systems, or a combination of those or comparable experiences. Tactical and strategic clinical and safety quality assurance experience required. Quality assurance, quality systems, and/or quality 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 vision 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-reliant, passionate, enthusiastic with focus 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
• Structured and well organized
• Willing to travel globally (25%)

Additional Details This job has a full time weekly schedule. It includes the option 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 range 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 range, 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 share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations reputed company, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at reputed company levels. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, 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 basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. reputed company, Inc., is committed to diversity in the workplace 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 [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility. Travel Required: 25% of the Time Shift: Day Duration: No End Date Job Function: Quality/Regulatory Apply tot his job