• Job Description

  Req#: R257537

  Job Description

  As an Individual contributor, this person is 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 Company policies. The successful candidate will be part of the EQA Compliance/System team, which will provide Quality oversight of Quality and Business processes with EQA and will also drive and participate in cross functional initiatives to develop and optimize Quality systems and business processes.

  Summary, Focus, and Purpose

  This role will be accountable for supporting the development, maintenance, and enhancement of critical processes and systems. The Senior Specialist will also be accountable 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.

  This position also requires the individual to ensure Quality Systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture of materials for the Company and 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 Company’s global network.

  Key Functions

  • 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
  • Supports the development, implementation, maintenance, and enhancement of critical processes, systems and master data such as COMET SAP, Supplier Transparency, Remedy, Collaboration sites and IPI
  • Maintains and provides expertise on ExN systems, tools, data, and processes on an ongoing basis, specifically COMET SAP via the use of specific T-Codes in COMET SAP
  • Provide ongoing systems SME support ensuring ExN data and processes run smoothly with no interruption to supply
  • Responsible, as needed, for serving on teams when IT and Business systems representation is needed related to any systems, data, or processes in relevant areas
  • Leads and facilitates the training sessions for EQA

  
  Minimum Education Requirement and Experience:

  • Bachelor of Science Degree (BS) in Science, Engineering, or other relevant technical discipline (e.g., Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred) and five (5) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
  • Master of Science Degree (MS) in Science, Engineering, or other relevant technical discipline (e.g., Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred) and three (3) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

  Required Experience and Skills:

  • Minimum one year in COMET SAP business workflow via T-Codes and material master data build experience
  • Strategic and effective analytical and computer skills, including software packages used in the maintenance and analysis of data
  • Ability to analyze complex business processes, develop and implement solutions, and communicate impact to stakeholders
  • Purposeful and effective interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships
  • Work across boundaries; demonstrated interpersonal, relationship building and leadership skills
  • Effective and strategic communication capabilities both verbal and written

  Preferred Experience and Skills

  • Supporting regulatory inspections
  • Conversant with all domestic and foreign regulations and compendia governing plant operations
  • Familiar with batch release process and quality notification process
  • Familiar with Master Data Governance

  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.

  Residents of Colorado

  Click here to request this role’s pay range.

  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

  Current Contingent Workers apply HERE

  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 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

  EEOC GINA Supplement

  Pay Transparency Nondiscrimination

  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

  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”.

  Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

  $77,100.00 - $153,700.00

  Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

  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):

  n/a

• About the company

  Merck & Co., Inc.

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