Description
Reporting to the Vice President of the Diagnostics and Genomics (DGG) Quality organization within Global Quality and Regulatory Affairs (GQRA), the Director of Clinical and Safety Quality Assurance will be responsible for setting strategy for and leading the Clinical and Safety Quality Assurance function for Agilent.
You will ensure that Agilent’s processes for clinical quality oversight of clinical trial conduct, clinical trial sites, and suppliers, as well as vigilance oversight of product quality issues are robust and in alignment with ICH E6, other applicable Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) regulatory requirements, and Agilent processes.
Patient needs, stakeholder demands, industry innovation, regulatory landscape, and Agilent’s evolved business strategy are complex and dynamic.
Emphasizing and embedding quality in the execution of clinical trials and vigilance activities assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of in vitro diagnostics development programs.
An elevated, focused, and evolved Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) strategy and pipeline partnership are essential.
You will be a key member of the DGG Quality leadership team and will work in close partnership with the DGG Quality leaders to execute the multi-year GQRA strategic roadmap.
Develop, implement, and ensure continuous improvement of the clinical and safety quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company polices.
Lead 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.
Develop lessons learned from regulatory inspections and promote knowledge management.
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 related operational processes.
Develop strategies to identify and mitigate related 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.
Develop 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 continuous improvement efforts.
Establish and maintain robust clinical and safety quality standard operating procedures (SOPs), and other related quality documents.
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
Provide leadership and oversight for training programs related 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 continuous 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.
Minimum of 5 years' experience formally or informally leading people, projects and / or programs.
5+ 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 excel and inspire 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 on a regular basis.
LI-PK1
The US pay range for this full-time position is $146, - $240,, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations.
Within the range, individual pay is determined by work location and additional factors, including job-related 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. Additional details are available at :
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels.
All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, 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.
Agilent Technologies, 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 or contact +1-262-754-5030.
For more information about equal employment opportunity protections, please visit
Option to Work Remote
Travel Required
35% of the Time
Shift
Duration
No End Date
Job Function
Quality / Regulatory
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