**Job Description** **Position Description:** + As a member of our Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for our Company's R&D division. + For our Company's Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications, end-user applications, laboratory instrument systems and manufacturing automation systems. + Provide independent Quality Assurance oversight for the implementation of new computerized systems, change control involved with existing computerized systems as well as the retirement of computerized systems in the Clinical Supply domain. + Develop and maintain a subject matter expert level of understanding for our Company Policies, Procedures and Quality Manuals governing computer system validation activities. + Endorse and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness. + Consult, assess and assist with risk based, tailored approaches for computer system validation activities and testing. + Develop and maintain an overall computer system validation posture and program for a defined functional area(s) (single point of contact) within Clinical Supply, including support for System Development Life Cycle deliverables and testing. + Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management. + As required, participate in Regulatory Agency inspection activities. + Deliver stewardship for our corporate initiatives from a Quality Assurance perspective, such as the Data Governance and Corporate Resiliency programs. + Identify and incorporate continuous improvements into computer system validation activities and standards. Leverage external affiliations in order to evaluate current trends. + Collaborate and establish relationships with key stakeholders in the Business and Technical Units, including external suppliers. **Position Qualifications** **:** **Education Minimum Requirement:** + B.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline. **Required Experience and Skills:** + Experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g., GLP, GMP) environment. + 5 years of industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions. + High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration. + High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management. + Extensive experience providing oversight for adherence to enterprise SLC and procedures. + Proficient skills dealing with and understanding typical laboratory facilities and equipment. + Proficient skills dealing with and understanding automation systems found on the operations shop floor. + Understanding of Pharma 4.0 and next generation information technology platforms. + Ability to prioritize and manage multiple initiatives, projects concurrently. + Excellent interpersonal skills including ability to work as a team member in a collaborative environment. + Excellent written and communication skills including thorough knowledge of Good Documentation Practices. + Possess excellent time management skills. + High attention to detail. **Preferred Experience and Skills:** + Experience with calibration and qualification. + Expertise with configuration management. + Knowledge of published regulatory agency data integrity, cloud computing, artificial intelligence guidance. + Moderate level of experience with electronic tools such as software providing document/content management and testing capabilities. + Some level of experience with IT Infrastructure Language and service management. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) **U.S. Hybrid Work Model** 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”. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected US salary range: $104,200.00 - $163,900.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) . **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 **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 **Search Firm Representatives Please Read Carefully** 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. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** No **Job Posting End Date:** 03/1/2025 ***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.** **Requisition ID:** R336952