Job Description

　　Individual contributor responsible for ensuring the compliance of Incoming Materials (IM) processes against approved quality manual documents and/or ensuring robust business systems in compliance with our Company policies. The incumbent will provide Quality oversight related to Quality Risk Management. The incumbent will also drive and/or participate in cross functional initiatives to develop and optimize Quality systems and business processes.

　　The incumbent will be responsible for supporting the development, maintenance, and enhancement of critical processes and systems. Additionally, the incumbent will be responsible for compiling, analyzing, and reporting of associated metrics, supporting the development and implementation of strategic projects, as well as the development and ongoing monitoring of performance.

　　The incumbent ensures that Quality Systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture of materials for our Company. The incumbent may also be part of the team providing Quality oversight of internal inspection preparedness and performance of internal audits. The role could require routine interactions with all functions across our Company’s global network.

　　Position Responsibilities:

　　Serves as Quality SME for IM; Maintains and provides expertise on business systems, tools, data, and processes on an ongoing basis.

　　Ensures that the organization operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.).

　　Provides support to the organization to facilitate and implement new quality systems introductions and/or improvements.

　　Assists with and/or lead the development, and ongoing execution of the Quality Systems.

　　Establishes new or improved processes, tools, systems and drives consistent, standard business processes.

　　Supports the compilation, analysis and reporting of metrics, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

　　Supports audit/inspection readiness of the organization and participates in regulatory and other quality and compliance report-outs; review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted).

　　Provides project management support of raw materials and components.

　　Primary liaison for Change Management related to incoming materials.

　　Supports QRA for site related to incoming operational areas, supplies inspection, and materials/components.

　　Minimum Education Requirement and Experience:

　　Bachelor of Science (BS) degree in Science, Engineering, or related area of study with five (5) years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements.Required Experience and Skills:

　　Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

　　Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

　　Communicates in English, both verbally and in writing.

　　Preferred Experience and Skills:

　　BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred.

　　Previous experience supporting regulatory inspections.

　　Be conversant with all domestic and foreign regulations and compendia governing raw materials and components

　　Strong project management skills

　　Experience with Quality Risk Management, External Entity Oversight, Quality Management System and SOP management as well as metrics reporting experience.

　　Experience working with -MEDS, Veeva Vault-QualityDoc, eVal, and MetricStream (RMS) systems.

　　NOTICE FOR INTERNAL APPLICANTS

　　In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

　　If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

　　Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

　　Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.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, generally Tuesday, Wednesday and either Monday or 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”.

　　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, On-Site

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　n/a

　　Requisition ID: R278186