Requisition ID: COM000791
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare .
This role is responsible for developing and executing risk-based processes that support all System Development Life Cycle (SDLC) activities relating to the Global IT Divisional systems to ensure compliance with Health Authority Regulations and other IT-related legal and security requirements.
This role supports external inspections, QA audits, and IT incidents & deviation investigations. Further, it includes leading investigators to develop and manage IT Compliance Investigation Reports (CIRs), IT Quality Variances, and the associated CAPA, which includes supporting determination of compliance impact on the business, leading the development of root cause and Corrective and Preventative Actions (CAPAs) planning across IT.
Responsibilities & Tasks
- Proactively collaborate with other ITRMS, IT, Compliance, and Quality organizations, as well as a broad client base to break-down organizational boundaries in favor of a highly collaborative culture which focuses on the investigation of identified risks and compliance issues.
- Author, and track to completion, IT systems incidents with a potential or definitive compliance impact that have an impact on the business.
- Lead the CIR and CAPA as well as IT Quality Variance processes in collaboration with IT divisional business and technical owners and regulatory areas.
- Partner with the IT Incident, Problem Management, Operational and Delivery teams as well as Divisional Quality and Regulatory teams in support of investigations in order to ensure the overall compliance posture of Global IT system is resilient and sustained.
- Develop risk-based processes to provide second level support for IT GxP inspections (where GxP could be Good Laboratory Practices [GLP] Good Clinical Practices [GCP], Good Manufacturing Practices [GMP], Good Distribution Practice [GDP] or Good Clinical Data Management Practices [GCDMP]) for above-site systems.
- Manage, in a timely matter Inspection support requests, Compliance Investigation Reporting, and Quality Variance investigation results and related risks to business and communicate and raise awareness about critical GxP inspection and QA audit risks, trends and emerging themes.
- Participate in response and mitigation plans for any regulatory external inspections findings (e.g., FDA 483) related to Global IT computerized systems.
- Collaborate with ITRMS Leaders and Business Process Owners to ensure CAPAs resulting from Compliance Investigation Reports, Variances, and Inspections are established and remediated.
- Demonstrate competence in development of IT operating procedures and use of supporting tools (e.g., IT Technical Bulletins, Incident/Problem/Change Control tools).
- Conduct SDLC assessments and Periodic Reviews, as needed, and assist the team responsible for that process.
Education Minimum Requirement:
- Bachelor's- or Master's degree in a science or technology discipline
- 5 years required experience in Quality, Regulatory, IT, or GxP/non-GxP Operations, with preferably 5 years of experience in IT compliance, quality or an regulatory area
- 3-5 Years of Systems Development Life Cycle experience
- Possess strong problem solving skills, Knowledge of GxP, Knowledge of SOX, technical writing, data management collection and analysis
- Demonstrated interpersonal skills including flexibility and ability to work in a team environment
- Innovative, analytical and inquisitive mindset: demonstrate the ability to adapt current work processes to meet emerging needs and changes in job responsibilities.
- Good administrative skills and the ability to work a strongly regulated environment.
- Ability to lead, support, and influence enterprise change initiatives
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org .
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
Job: Compliance & Risk Management
Other Locations: Branchburg, NJ, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: No
Company Trade Name: Merck
Nearest Major Market: Philadelphia