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Senior Specialist Compliance & Risk Management EMEA Job

Date: Nov 8, 2017

Location: Haarlem, NH, NL

Company: MSD

Requisition ID: COM000559

MSD 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 MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


 


MSD’s Information Technology division partners with colleagues across the business to help serve our patients and customers around the world. Ours is a high-energy team of dynamic, innovative individuals dedicated to advancing MSD’s contribution to global medical innovation by leveraging information and technology to efficiently advance the business by driving revenue and productivity.


 


The Role
In this role it is your responsibility to develop and execute risk-based processes that ensure IT Inspection Readiness for Health Authority Regulated IT systems and other IT-related legal and security requirements.

You will support external inspections and System Development Life Cycle (SDLC) Assessments/Sustainment. You will apply the Compliance Investigation Reporting Process (CIRs) to include determination of business impact and root cause/Corrective and Preventative Action (CAPA) analyses for IT, Enterprise wide.

As our IT Risk Management Senior Specialist you will :



  • work across other market divisions and IT colleagues to drive collaboration, efficiencies and reusability

  • act as a bridge between the IT compliance aspects of all markets to ensure alignment with regulatory and company requirements.

Responsibilities & Tasks



  • Ensure and promote collaboration with other IT divisions, in market, as well as parts of the MSD business, to break-down organizational boundaries in favor of a highly collaborative and customer-centric culture

  • Mentor authoring, and track to completion, all IT production incidents with a potential or definitive compliance impact that have an effect on the business

  • Liaise with the Incident- and Problem Management team

  • Develop risk-based processes to ensure 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])

  • Raise awareness about critical GxP inspection readiness risks and vulnerabilities

  • Manage and communicate Inspection, and Compliance Investigation Reporting results and related risks to business and IT leaders

  • Participate in response and mitigation plans for any regulatory/audit finding (e.g., FDA 483) related to computerized systems

  • Collaborate with ITRMS Leaders and Business Process Owners to ensure proper CAPAs are established and remediated for IT Compliance Investigations and internal audits

  • Demonstrate competence in development of IT operating procedures and use of supporting tools (e.g., IT Technical Bulletins, Incident/Problem/Change Control tools such as Remedy, etc.) as required

  • Conduct SDLC assessments and assist the team responsible for that process

  • Assist leadership with providing trending analytics for ITRMS monthly scorecards and risk registers.

Qualifications

 



  • Bachelor's- or Master's degree in a science or technology discipline

  • 7 years preferred minimum of experience in Quality, Regulatory, Technical, or GxP/non-GxP Operations

  • Knowledge of cGxPs, technical writing, data management collection and analysis

  • Demonstrated interpersonal skills including flexibility and ability to work in a team environment

  • Innovative mindset: demonstrates 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.

About MSD
A good place to work. MSD is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators. MSD always seeks ‘best-in-class’ employees at all levels. We expect a lot from our people and MSD has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD values and rewards most. If you enjoy being challenged, over and over again, MSD will be a good place for you to work. We have an excellent fringe benefit program, and we invest heavily in the development of our people. MSD gives you plenty of opportunities for individual initiative and responsibility.

About the Department
The ITRMS department in EMEA is part of the global IT Risk Management and Security (ITRMS) organization. The EMEA team will exist of 4 colleagues, who interact with business as POC for IT Inspection Readiness along with Incident/Compliance Investigation Report (CIR)CIR handling for computerized systems. The Team closely collaborates with regional as well as global IT Teams.

Application:
If you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter.

More information
For more information on this vacancy you can contact Harry Vuijk, Associate Director, Compliance & Risk Management, tel: +31 23 515 3574.


 


 


Search Firm Representatives Please Read Carefully:
MSD 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 MSD 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 MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Compliance & Risk Management
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Company Trade Name: MSD


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