<p>Job Description</p> <p>We are seeking a dedicated professional to ensure and maintain compliance with customer requirements and regulatory standards. This position holds a wide variety of Quality related activities to ensure compliance with applicable regulatory requirements. This includes, but is not limited to, overseeing Quality System programs, participating in audits, documentation reviews, data analysis, developing program metrics and communicating program status to senior leadership.</p> <p>Job Responsibilities:</p> <ul> <li> <p>Oversee the implementation and maintenance of quality systems to ensure compliance with regulatory standards and company procedures.</p> </li><li> <p>Plan and implement multiple tasks to ensure quality tasks are completed on time and per procedures for projects that require strategic decision-making.</p> </li><li> <p>Develop actionable metrics and identify remediation plans to ensure site compliance to Quality Systems. Present program-owned data to senior leadership, including appropriate actions to be taken to improve site performance related to responsibility.</p> </li><li> <p>Lead Quarterly Management review meetings and communicate program requirements and oversight responsibilities to auditors.</p> </li><li> <p>Provide support for site Regulatory and client audits as requested.</p> </li><li> <p>Develop and maintain Standard Operating Procedures (SOP's) and conduct ongoing training sessions to maintain program certification requirements.</p> </li><li> <p>Ensure investigations for Change Controls, Nonconformances, and Out of Specification investigations are performed according to site procedural and Regulatory requirements.</p> </li><li> <p>Lead TMS activities associated with system ownership and develop TMS Quality System workflows.</p> </li><li> <p>Lead various projects as necessary, ensuring the precision, accuracy, and reliability of the GMP process and timely delivery.</p> </li><li> <p>Continuously identify and implement QS program improvements to support compliance and site efficiencies.</p> </li><li> <p>Solve a broad range of problems of varying scope and complexity, providing strategic solutions to enhance overall quality systems.</p> </li></ul> <p>Qualifications</p> <ul> <li> <p>Bachelor's or Master's Degree or equivalent plus directly relevant experience.</p> </li><li> <p>8+ years experience in Quality for a biotech / pharmaceutical environment.</p> </li><li> <p>Demonstrated experience developing remediation plans to ensure site compliance.</p> </li><li> <p>Experience leading TMS activities.</p> </li><li> <p>Must have experience with change controls, nonconformance, and Out of Specification investigations.</p> </li><li> <p>Prior experience preparing and participating in regulatory and client audits.</p> </li></ul> <p>#LI-DT1</p> <p>Additional Details</p> <p>This job has a full time weekly schedule. Applications for this job will be accepted until at least June 9, 2025 or until the job is no longer posted.</p> <p>The full-time equivalent pay range for this position is $111,840.00 - $174,750.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. 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. Pay and benefit information by country are available at: https://careers.agilent.com/locations</p> <p>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.</p> <p>Travel Required:</p> <p>10% of the Time</p> <p>Shift:</p> <p>Day</p> <p>Duration:</p> <p>No End Date</p> <p>Job Function:</p> <p>Quality/Regulatory</p>