Job Description
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
Information Technology Risk Management and Security Governance Risk and Compliance (ITRMS GRC) is an essential component of the current IT enterprise that provides support to the Pharmaceutical Research, Supply Chain and Marketing organizations. The IT Compliance Services Sr. Specialist is a member of this team and is responsible to work independently and in collaboration with the Business and Technical Units to comply with the System Life Cycle (SDLC) Policy. They partner with Business and Technical Units to gather objective evidence that the software, hardware, equipment, operating procedures, total solution and operational environment consistently produces all pre-determined requirements. The IT Compliance Services Sr. Specialist also provides training and guidance to the team concerning the authoring of SDLC and validation deliverables, good documentation and testing practices.
This role reports to the ERP Compliance & Lifecycle Quality Services Line Lead.

• Continuously monitors the status and performance of assigned service area
• Supports service demand, delivery, and resources within assigned service area
• Works with Service Line Lead to identify opportunities for improvement within assigned service area
• Acts as a point of risk and issue escalation for resources within the service area
• Responsible for tracking of metrics for success measurement
• Responsible for executing the activities associated with ERP Compliance & Lifecycle Quality Services service line.
• Responsibilities may include:
  
  • Provide release and operational support for ERP and other AH and HH global GxP systems.
  • Review and approval of SDLC (Plans, Specifications, Testing, Summary reports) documentation.
  • Author/review QAP and QASR
  • Provide Inspection Readiness to include SAP SOX IT Controls
  • Provide CAPA/Deviation Support
  • Provide Operational Support for SAP
  • Participate in SAP FireFighter Process
• Responsible to work independently and in collaboration with the Business & Technical (IT) Unit to document requirements, specifications, and testing of the IT solutions that enable the business. Partner with Business and Technical to gather objective evidence that the software, hardware, equipment, operating procedures, total solution and operational environment consistently produces all pre-determined requirements.
• Provides training and guidance to the team concerning System Development Life Cycle (SDLC) Policy requirements, validation deliverables, good documentation and testing practices to meet corporate policy and regulatory inspection requirements.
• Serves as an expert on Compliance policies. Maintains current state awareness and understanding of internal and industry practices relative to IT security & compliance. Knowledgeable of evolving trends, regulated industry regulatory requirements and citations, to stay abreast of the expectations for computer systems during regulatory inspections.
• Conducts analysis of any changes in existing policies as a result of a change in regulatory expectations, corporate policies or adoption of new quality policies within the regulated businesses (e.g. in cooperation with Business Units such as Manufacturing, Research, Animal Health and Human Health divisions). As needed, performs research to ensure proper understanding of regulations.
• Business proficiency of English language.
• Excellent verbal and written communication skills, with ability to communicate at multiple levels within the organization.
• Weekend work may be required to support IT system releases.

Required Qualifications/ Education:

• A Bachelor's Degree is required. Concentration in Engineering, Sciences, Information Systems or related field preferred.
• 8+ years working in IT Quality or Compliance in Life Sciences;
• 3-4 + years working in IT domain focus area (e.g. R&D, ERP, etc.)
• Experience in IT Risk and Compliance Management
• Technical knowledge and understanding of System Development Life Cycle and GxP principles and computer Validation.
• Experience in performing SDLC Technical Writing.
• Experience in SAP FireFighter Process
• Understanding of IT infrastructure, computer networking, databases (e.g. Oracle) or software development.
• Strong analytical and organizational skills
• Detailed knowledge of IT governance framework
• Broad-based knowledge of technology solutions (e.g. digital)
• Practical (in application of current governance controls)
• Experience working in a consulting or client-facing role is a plus

• Experience in system enhancement, implementation and upgrades.
• Change Management experience.
• Understanding of emerging technologies used in the IT industry, such as cloud, mobility, social, data science and analytics platforms.
• Business Proficient knowledge of English language in combination with excellent verbal and written communications skills.
• Demonstrated ability to work independently and as part of Global virtual teams in a fast-paced environment.

Preferred Experience and Skills:

• Experience with SDLC or equivalent system lifecycle approaches preferred.
• Experience with regulated GxP Pharmaceutical IT Systems.
• Relevant certifications a plus (AGILE, etc.).
• Experience working in a consulting or client-facing role is a plus.
• Experience with IT Risk and Compliance Management
• Standardization of delivery.
• Organizing under domain expertise
• Detailed knowledge of IT governance framework.
• Broad-based knowledge of technology solutions (e.g. digital, Remedy, Midas testing tools).
• Practical (in application of current governance controls).
• Natural curiosity and a desire to do things differently.
• Consultative
• Assertive
• Nice to have: Certification in Agile and/or SAP

GRC2021
Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
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.
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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.
For more information about personal rights under Equal Employment Opportunity, visit:
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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
3