Director, Quality Risk Management

Job Description
The Director, Quality Risk Management within Global Quality Compliance & Systems (QCS) provides strategic direction and leadership for Agilent's product and process Risk Management framework across business groups and product lines. This network leader role partners with business unit and divisional Risk Management professionals to establish, further evolve and sustain processes, procedural controls, and governance elements related to Quality Risk Management. Reporting to the Associate Vice President Compliance in QCS, this position is crucial in maintaining and continually improving Agilent's compliance posture and assumes ownership of foundational compliance processes and governance.
Key responsibilities include:

• Lead the development, governance, and ongoing operation of Agilent's product and process Quality Risk Management program to ensure compliance with regulatory requirements and drive improvements to product quality.
• Act as Process Owner for all aspects of Risk Management including the collaborate with related processes throughout the product lifecycle (e.g., Design Control, Post Market Surveillance).
• Continually improve the Quality Risk Management process with a focus on harmonization and integration.
• Provide strategic guidance, technical expertise, and program management for remedial activities related to Risk Management files.
• Partner with R&D, Quality, Vigilance, Medical Affairs, and Clinical Affairs to align risk assessment approach across all product safety related processes.
• Keep abreast of industry trends and regulatory intelligence related to Agilent's business focus, and lead/support the assessment and update of relevant GxP processes and systems as the need arises.
• Serve as a senior-level Subject Matter Authority for Quality & Compliance related issues, lead and/or support sophisticated investigations and drive risk-based actions, issue resolution and continual improvement across the network.
• Serve as a strategic thought partner to the AVP Compliance and the Global Quality Compliance & Systems Leadership Team with regard to sophisticated problems, risk identification, risk mitigation, and other aspects of Risk Management.

Qualifications

• Bachelor's or Master's Degree or equivalent
• Broad knowledge of functional area(s) of responsibility
• 5+ years experience formally or informally leading people, projects and/or programs and leading diverse, global teams, either in a line or network leadership capacity
• 10+ years of industry experience, with growing managerial responsibility and/or matrix leadership in a life science environment
• 7+ years of experience with leading Quality Systems in a life science/pharmaceutical environment (pharma, biopharma, medical device), with a strong focus on Risk Management (processes, controls, governance)
• Master level subject matter expertise in Risk Management for medical devices according to ISO 14971. Ability to train others in the technical aspects of Risk Management
• Expert knowledge of ISO 9001, ISO 13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, 21 CFR pt. 11. Additional experience in the biopharmaceutical environment, e.g. ICH Q9 is a plus
• Demonstrated ability to interface with senior executives and cross-functional teams, and strong proven ability to influence and drive change
• Strong leadership and team building skills
• Experience in leading complex organizational challenges and identifying and successfully executing corporate-level strategic initiatives and priorities
• Demonstrated ability to effectively prioritize with a sense of urgency
• Experience in operating in a multi-disciplinary life science environment
• Excellent written and verbal communication skills
• Fluency in written and spoken English

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The US pay range for this full-time position is $173,035.00 - $270,368.00/yr, 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: https://careers.agilent.com/locations/americas/united-states/
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 job_posting@agilent.com or contact +1-262-754-5030.
For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.
Option to Work Remote
Yes
Travel Required
25% of the Time
Shift
Day
Duration
No End Date
Job Function
Quality/Regulatory