Senior Specialist – Digital & Data Quality

Job Description

Our Quality Assurance (QA) group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

This QA Senior Specialist in Digital and Data Quality will be responsible for the quality/compliance, remediation, support, and quality aspects of our Enterprise Resource Planning Application.  This position will work directly with Business Process or Data Owners and Technology Support & Delivery services over the life cycle of the in-scope application. This quality role shall include global and all local site requirements. This Global QA role will include purview of Enterprise Resource Planning.

Primary Activities include, but are not limited to:

• Supporting the preparation, review, and approval of documentation related to validation and quality operation of above requirements including core requirements, policies, guidelines, SOPs, testing, document reviews and approvals, and training with the focus on driving consistency of requirements and system functions

• Test Documentation within an Agile Methodology
• Continuous Lifecycle Process through the agile methodology.
• Relevant experience with emphasis on functional and technical knowledge.
• Business engagement skills, an ability to partner with both technical and non-technical roles.
• Strong stakeholder engagement skills with demonstrated success in Change Management.
• Background in GMP Change Management, Incident and problem management, and SAP is required.
• Ability to understand business needs and map to IT technical solutions.
• As part of this Quality Unit (QU) role, review and approve ERP changes.
• Work in dynamic environment and global teams.
• Experience working across countries in a multi-cultural environment.
• Partner with our company IT Risk Management organization and our primary customers / business partners while maintaining oversight of the Quality drivers.

Minimum Education Requirement and Experience:

• Bachelor’s Degree in Computer Science or Engineering with five (5) years’ experience in Enterprise Resource Planning testing and quality

Required Experience and Skills:

• Three (3) years in regulated pharmaceutical manufacturing industry
• Strong comprehension of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations
• Extensive knowledge of the principles, theories, and concepts of computerized system validation/compliance
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment
• Limited supervision required in day-to-day activities

Preferred Experience and Skills:

• SAP experience
• Professional Certifications (e.g., Six Sigma or certification in Project Management (PMP)
• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
• Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations
• Direct experience in a Quality and/or Compliance role in a GMP environment
• Business engagement skills, with ability to partner with both technical and non-technical roles
• Multi-lingual capabilities
• Principled verbal and written communication skills including persuading others and developing cross functional relationships both at site and across sites
• Analytical Problem-solving skills applied to issue identification and resolution
• Listening, integrating diverse perspectives, adds value to the achievement of team goals
• Timely decision making
• Project management skills combined with a since of urgency and a proven history producing quality deliverables
• Ability to respond to changing priorities
• Inclusion behaviors
• Coach and provide technical/compliance guidance to others

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

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 State, 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:

$101,100.00 – $159,100.00

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.

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:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st – Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/14/2024

*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.