<p>Job Description</p> <p>The mission of our company's Research Laboratory Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.</p> <p>The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research Laboratory Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).</p> <p>The Global Quality Systems role reports to the Clinical Supply Quality Systems Strategy Lead, within CQMS. This role supports the digital enhancements of quality systems, such as document control, deviation management, change control and quality risk management and additional IT solutions quality system modules for these areas.</p> <p>The primary duties of this role include, but are not limited to:</p> <ul> <li> <p>Provide key quality systems support and ensure that systems and processes are operating in a state of control and in compliance with regulatory requirements and internal SOPs.</p> </li><li> <p>Support the quality systems digital strategy and IT roadmap.</p> </li><li> <p>Support the planning, coordination, implementation, and organizational change management of IT initiatives from a business perspective, such as system enhancements and automation to improve clinical supply GMP processes.</p> </li><li> <p>Provide support and guidance to cross-functional teams in the implementation of digital projects, ensuring successful delivery on time and within budget.</p> </li><li> <p>Collaborate with stakeholders to identify and prioritize quality systems technology and digital transformation opportunities</p> </li><li> <p>Help to curate enhancement requests, facilitate requirement discussions with the business areas to create JIRA items, adding crucial details, value assessments, and prioritization</p> </li><li> <p>Conduct assessments to help prioritize areas for quality system improvement in support of the Clinical Supply QMS, leveraging digital solutions and emerging technologies.</p> </li><li> <p>Coordinate and conduct UAT testing activities</p> </li><li> <p>Monitor and evaluate the performance of digital initiatives, tracking key metrics, and providing recommendations for continuous improvement.</p> </li><li> <p>Monitor data quality and administrative activities related to IT solutions</p> </li><li> <p>Create release notes for system enhancements in a clear and concise manner to ensure end users fully understand the changes and their impact.</p> </li></ul> <p>Education Minimum Requirement:</p> <ul> <li>B.S. degree in an appropriate science or computer science, engineering, or business discipline with a minimum of three (3) years experience in the Pharmaceutical or equivalent industry or five (5) years of experience (equivalent). </li></ul> <p>Required Experience and Skills:</p> <ul> <li> <p>Knowledge of digital technologies, data analytics, system integration, and emerging trends in digitalization in the healthcare or pharmaceutical industry.</p> </li><li> <p>Knowledge of regulatory requirements and industry standards related to digital solutions and data in the healthcare or pharmaceutical industry.</p> </li><li> <p>Excellent communication and presentation skills with the ability to effectively collaborate with cross-functional and cross-divisional teams and stakeholders at all levels.</p> </li><li> <p>Ability to prioritize and manage multiple projects simultaneously, ensuring timely delivery and meeting business objectives.</p> </li><li> <p>Highly organized with effective project management skills and a track record of successfully delivering IT projects.</p> </li></ul> <p>Preferred Skills:</p> <ul> <li> <p>Previous background directly related to quality assurance, quality systems, auditing, quality management systems or other GMP compliance activities.</p> </li><li> <p>Experience with Veeva Vault Quality Platform</p> </li><li> <p>Working knowledge of Agile Methodology</p> </li><li> <p>Effective negotiation and problem-solving skills.</p> </li><li> <p>Ability to lead teams in a matrix organization to achieve objectives, including collaboration, influence without authority.</p> </li></ul> <p>Current Employees apply HERE</p> <p>Current Contingent Workers apply HERE</p> <p>US and Puerto Rico Residents Only:</p> <p>Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.</p> <p>As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:</p> <p>EEOC Know Your Rights</p> <p>EEOC GINA Supplement</p> <p>We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.</p> <p>Learn more about your rights, including under California, Colorado and other US State Acts</p> <p>U.S. Hybrid Work Model</p> <p>Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".</p> <p>The salary range for this role is</p> <p>$104,200.00 - $163,900.00</p> <p>This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.</p> <p>The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.</p> <p>We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.</p> <p>You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.</p> <p>San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance</p> <p>Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance</p> <p>Search Firm Representatives Please Read Carefully</p> <p>Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p> <p>Employee Status:</p> <p>Regular</p> <p>Relocation:</p> <p>No relocation</p> <p>VISA Sponsorship:</p> <p>No</p> <p>Travel Requirements:</p> <p>10%</p> <p>Flexible Work Arrangements:</p> <p>Hybrid</p> <p>Shift:</p> <p>1st - Day</p> <p>Valid Driving License:</p> <p>No</p> <p>Hazardous Material(s):</p> <p>No</p> <p>Required Skills:</p> <p>Adaptability, Audits Compliance, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, Interpersonal Relationships, IS Audit, Management Process, Manufacturing Processes, Manufacturing Quality Control, Process Improvements, Quality Assurance Systems, Quality Risk Management, Technical Writing, University Education, Validation Processes</p> <p>Preferred Skills:</p> <p>Job Posting End Date:</p> <p>07/11/2025</p> <ul> <li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. </li></ul> <p>Requisition ID:R353931</p>