Job DescriptionIndividual contributor responsible for ensuring the compliance of External Quality Assurance (EQA) processes against approved quality manual documents and/or ensuring robust business systems in compliance with our Company policies. The incumbent will be part of the EQA QRM CoE within the EQA Compliance/System team, which will provide Quality oversight of Quality and Business processes with EQA 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 financial plans and 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 supporting the External Network, including interaction with functions across our Company’s global network.Position Responsibilities:
Serves as Quality SME for EQA; Maintains and provides expertise on EQA quality and/or 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.) both domestic and foreign.
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 across EQA.
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 EQA.
Assists in the preparation and coordination of Quality Senior Management presentations at management conferences, training programs, Quality Council, etc. Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.
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; OR Master of Science (MS) degree in Science, Engineering, or related area of study with three (3) 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.
Prior management experience preferred.
Moderate level of contractual and financial awareness
Previous experience supporting regulatory inspections.
Be conversant with all domestic and foreign regulations and compendia governing plant operations.
Strong project management skills
Trained Quality Risk Management (QRM) Facilitator
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-Quality Doc and MetricStream (RMS) systems.
NOTICE FOR INTERNAL APPLICANTSIn 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.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/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.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 ModelEffective 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:$101,100.00 - $159,100.00Available 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 OrdinanceLos 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 OrdinanceSearch Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:10/28/2024A 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: R318498
